Location: Belgrade, Serbia; Warsaw, Poland; Madrid, Spain; Prague, Czechia; Sofia, Bulgaria; Budapest, Hungary
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Site Contract& Budget (SCBM) to join our A-team (hybrid*/remote) in Europe! The SCBM is responsible for supporting the Site Contract negotiation activities. The SCBM supports the Site Contract & Budget leadership with lessons learned, experience sharing and work collaboratively with internal stakeholders to achieve timely delivery of site contract and budget execution.
In this role your key tasks will include:
Lead and oversee site contract and budget activities across assigned clinical studies, ensuring timely negotiation, execution, and delivery in accordance with study timelines and sponsor requirements.
Develop and maintain study-specific Clinical Trial Agreement and Budget Plans (CTABPs), including contracting strategies, negotiation parameters, and escalation pathways.
Coordinate and provide guidance to Site Contract & Budget Associates and other country-level resources involved in contract and budget negotiations.
Serve as the primary point of contact for sponsors and internal stakeholders regarding site contracting processes, negotiation strategies, progress, and escalations.
Review, adapt, and coordinate approval of master, country-specific, and sponsor-provided CTA templates, ensuring alignment with applicable local regulations, sponsor requirements, and internal procedures.
Provide contractual expertise and negotiation support, including review of complex contractual issues, development of fallback language, and final quality review of negotiated site agreements.
Monitor contracting milestones, maintain accurate status reporting, proactively identify risks and delays, and implement appropriate mitigation and escalation measures.
Oversee site contractual documentation throughout the study lifecycle, including amendments, termination letters, and contracting activities during study maintenance and closeout.
Requirements
Bachelor’s Degree in Healthcare or Biological Science and minimum 3 years of experience in drug development and/or clinical research; or equivalent combination of education, training, and experience
Minimum 3 years of Site Contract & Budget experience
Paralegal certification preferred contract review or budget negotiation experience
Knowledge of privacy legislation (GDPR and/or HIPPA) and ICH-GCP
Good computer skills with good working knowledge of a range of computer programs including word, excel and CTMS systems.
Strong negotiation skills
Strong written and verbal communication skills
Good organizational and time management skills
Attention to details
Technical writing experience is a plus
Experience working with cross-functional teams is a plus
Ability to travel domestically and internationally as required.
Ability to effectively attend and present at internal and external meetings (such as internal, Sponsor’s or Bid Defense meetings)
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-BL1
Location: United States
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Looking to take your project management expertise to the next level? Join us as a
Project Manager II (PM II)
and lead the delivery of complex clinical trials that make a meaningful impact for patients worldwide. We are seeking a strategic and execution-focused leader with strong experience managing
Oncology
clinical trials who thrives in a fast-paced, collaborative environment.
About the Role
As a Project Manager II, you will lead with impact and drive global clinical trials from study start-up through final delivery. You’ll oversee cross-functional teams, ensuring studies remain on track, on budget, and compliant with GCP and regulatory requirements while serving as the primary point of contact for sponsors, vendors, and internal stakeholders. With a focus on proactive problem-solving, risk mitigation, and operational excellence, you’ll play a critical role in delivering high-quality clinical programs that exceed client expectations.
Your main responsibilities will include but not limited to:
Driving project success by leading cross-functional teams to deliver clinical trials on time, within scope, and on budget.
Ensuring excellence and compliance by developing and executing project plans aligned with GCP, SOPs, and regulatory standards.
Aligning stakeholders by serving as the primary point of contact for sponsors, vendors, and internal teams.
Optimizing vendor performance through strategic selection, management, and oversight.
Mitigating risks and control budgets by proactively addressing challenges, scope changes, and resource allocation.
Maintaining inspection-ready documentation by leading key meetings and ensuring the Trial Master File and study records are complete.
Requirements
About You
If you are a results-driven Project Manager II with a proven track record of leading complex clinical trials from start-up to closeout. If you thrive in fast-paced environments, excel at aligning teams and stakeholders, and take pride in delivering projects on time, on budget, and with uncompromising quality then this role is for you.
To be successful, we are looking for the following traits and behaviors:
Minimum Bachelor’s degree in life science, healthcare and/or business degree
Minimum 6 years of relevant work experience, specifically experience in drug development and/or clinical research
Minimum 1 year of project management experience, specifically as a clinical project manager
Strong expertise managing the unique operational complexities associated with Oncology programs, including oversight of specialized vendors, timelines, safety considerations, and global study execution.
Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
Demonstrates strong financial acumen, administrative excellence and analytical skills
Experience managing all phases of the full-service clinical trial delivery lifecycle (Start-up, Maintenance, Close-out).
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we
SHINE
. Find more information about our values.
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Apply now!
If you are interested in this role, please apply through the button or for more information reach out to Demetria Eggleston at Demetria.eggleston@allucent.com
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-Remote #LI-TCW
Location: Madrid, Spain
Allucent is a global full-service contract research organization dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light.
Our clients have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
We are looking for a
Clinical Trial Associate I
to join our team in
Madrid - Spain
! The Clinical Trial Associate (CTA) acts as the primary administrative support to Allucent clinical study teams at Country/Site level, to support Clinical Trial Operations and Sponsors, thus ensuring that the clinical trial is conducted in accordance with international regulatory and local regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures. The CTA also assists the study team with the day-to-day conduct of international clinical studies.
Location: Madrid, Spain
Workplace: Office based
Key Responsibilities
eTMF
Performs quality check of documents prior to eTMF submission to ensure the documents meet specifications to be complete and accurate for filing.
After quality check acts as Document Submitter and submits country and site level documents to eTMF Document Inbox. Resolves rejections.
Assists with resolution of periodic QC findings for country and site eTMF.
Communicates with the TMF Lead / Project Specialist to follow-up on country and site level eTMF status.
Updates Expected Documents List (EDL) in eTMF for the country and site level.
Maintains Public Folders in accordance with Study Correspondence Management Plan
ISF/PSF
Prepares and distributes Investigator Site Files (ISFs/eISFs), Pharmacy Site Files (PSFs/ePSFs) or other files needed for Site Initiation Visits (SIVs).
Prepares and maintains QC/Inventory Checklists for the ISFs/PSFs to support CRA with preparation to site visits and paperwork after site visits.
Assists CRA with reconciliation of ISF/PSF vs. TMF and cooperates with TMF Specialist and PS (Project Specialist)/TMF Lead to ensure inspection readiness of the TMF.
Other Responsibilities
Accurately updates and maintains site level CTMS, as needed and assist the project team with CTMS reports at requested intervals to follow-up on pending entries
Prepares and distributes clinical trial supplies to the investigational sites and maintains tracking information
May participate in feasibility and/or site identification activities.
If required, provides local support for organization of Investigator Meeting or any other study meeting organized in the country where CTA is located
Requirements
High School Diploma/Certificate or equivalent combination of education, training and experience; bachelor’s degree or equivalent (BS/BA) preferred
Experience of at least 1 year as CTA Trainee or 2 years within a similar role within clinical research preferred
Comprehensive Knowledge in Good Clinical Practices, Good Documentation Practices and Medical Terminology. on Practices
Fluency in Spanish and English (spoken and written)
Strong verbal and written communication skills
Computer literacy, proficiency in Microsoft Office
Ability to work independently and to effectively prioritize tasks with minimum guidance and oversight
Ability to manage multiple projects
Ability to establish and maintain effective working relationships with co-workers and managers
Basic knowledge of medical terminology and clinical monitoring process
Benefits
Competitive salaries and a comprehensive benefits package
Departmental Study/Training for furthering professional development
Mentoring opportunities
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our internal employee recognition programs for going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we
SHINE.
find more information about our values.
Apply now!
If you’re ready to bring your passion for clinical development and business growth to Allucent, apply today!
Disclaimers:
This role is fully office based (5 days per week in on-site)
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes
Location: Paris, France
About Allucent™
At Allucent™, our mission is to shine a light on new therapies that improve lives. When you join our team, you’ll use your unique skills, expertise, and knowledge to forge meaningful partnerships with clients while helping them turn groundbreaking ideas into life-changing treatments.
If you’re passionate about advancing pharmaceuticals and biologics, fueled by an entrepreneurial spirit, and eager to collaborate with top minds across science, business, and operations, we’d love to connect. Together we can accelerate innovation and grow side by side, making a last impact on patients worldwide.
Together we
SHINE
. Find more information about our values.
The role
Bring your monitoring expertise to the forefront of innovation.
We are looking for a
Clinical Research Associate (CRA)
to join our A-team. As a CRA at Allucent™, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.
As a
CRA
, you will take the lead on monitoring activities, owning your sites and relationships with investigators. You’ll be the bridge between sponsor and site, ensuring trial integrity while being supported by a collaborative, experienced team. This includes work related to regulatory affairs, site activation processes—including contracting and start-up activities—to ensure smooth and compliant study execution. You will travel throughout France.
Main responsibilities:
Independently manage all aspects
of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
Ensure compliance
with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
Build strong site relationships
, acting as a primary point of contact and ensuring high-quality data collection.
Identify and resolve site issues
, escalating as needed to maintain trial integrity and patient safety.
Activities around
regulatory affairs, site activation
and
study-startup.
Requirements
To be successful you will possess:
You’re an experienced CRA ready to take the next step with a company that truly values your expertise and independence. You thrive in an agile, collaborative environment and want to be part of a team making a real impact.
Experience in leading monitoring activities in complex trials with a minimum of 2 years’ experience.
Strong understanding of
ICH-GCP
and
regulatory guidelines
.
Clear and confident communicator in
English
and
French.
Comfortable working independently and managing priorities.
Willingness to travel, as required (8 DOS per month).
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-BL1
Location: Cary, United States
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
About the Role
Bring your expertise in regulatory affairs and join Allucent as a
Regulatory Affairs Scientist I
to assist clients with regulatory affairs related activities for drug, biologic, or medical device products and serve on project teams in various capacities such as Subject matter Expert, Assistant Consulting Lead, and Consulting Lead.
Your main responsibilities will include but not limited to:
Prepare and review regulatory and scientific documents for drugs, biologics, or devices, ensuring accuracy, quality, and compliance across development and lifecycle stages.
Support regulatory strategy and Health Authority (HA) interactions, including briefing materials, meeting preparation, responses to inquiries, and reporting requirements.
Translate regulatory guidance and submission requirements into practical plans, including eCTD submissions, change impact assessments, and post-approval regulatory activities.
Collaborate with clients and cross-functional teams while building regulatory expertise, staying current on evolving regulations, and mentoring junior team members.
Requirements
About you
Based near Cary, NC and able to come into the office 2-3 times per week.
B.Sc., M.Sc., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
Regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for US, EU, and / or Canada
>1 years’ experience with regulatory requirements of US FDA, Health Canada and / or European authorities.
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we
SHINE
. Find more information about our values.
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-TCW #LI-onsite #LI-hybrid
Location: Belarus
Bring your monitoring expertise to the forefront of innovation.
We are looking for a
Contractor Clinical Research Associate (CRA)
to join our A-team (hybrid). As a CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. At Allucent we are big enough to deliver and small enough to care. We know all our colleagues by name and work together as a team to make everyone SHINE.
The role
As a
Contractor CRA
, you will take the lead on monitoring activities, owning your sites and relationships with investigators. You’ll be the bridge between sponsor and site, ensuring trial integrity while being supported by a collaborative, experienced team. This includes work related to regulatory affairs, site activation processes—including contracting and start-up activities—to ensure smooth and compliant study execution. You will travel throughout Israel.
Main responsibilities:
Independently manage all aspects
of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
Ensure compliance
with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
Build strong site relationships
, acting as a primary point of contact and ensuring high-quality data collection.
Identify and resolve site issues
, escalating as needed to maintain trial integrity and patient safety.
Activities around
regulatory affairs, site activation
and
study-startup.
Requirements
You’re an experienced CRA ready to take the next step with a company that truly values your expertise and independence. You thrive in an agile, collaborative environment and want to be part of a team making a real impact.
Experience leading monitoring activities in complex trials, ideally in oncology or rare disease with a minimum of at least 5 years’ experience.
Strong understanding of
ICH-GCP
and
regulatory guidelines
.
Clear and confident communicator in
English and local language.
Comfortable working independently and managing priorities.
Willingness to travel, as required.
About Allucent
At Allucent, our mission is to shine a light on new therapies that improve lives. When you join our team, you’ll use your unique skills, expertise, and knowledge to forge meaningful partnerships with clients while helping them turn groundbreaking ideas into life-changing treatments.
If you’re passionate about advancing pharmaceuticals and biologics, fueled by an entrepreneurial spirit, and eager to collaborate with top minds across science, business, and operations, we’d love to connect. Together we can accelerate innovation and grow side by side, making a last impact on patients worldwide.
Together we
SHINE
. Find more information about our values.
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
Location: Amsterdam, Netherlands; Ireland, United Kingdom; Munich, Germany; Paris, France; Testelt, Belgium
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Sr. Clinical Data Manager (SrCDM) to join our A-team (hybrid*/remote). As a SrCDM at Allucent you lead data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.
In this role your key tasks will include:
Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)
Plan and project the resources required including management of tasks, timelines, risk and quality
Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition.
Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements
Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs)
Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed
Create training materials for EDC users and provide project-specific training as required
Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness
Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance
Organize and lead Quality Review activities during study
Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA)
Manage the database maintenance, lock and close-out processes and procedure
Participate in conference calls and/or meetings with vendors and sponsors
Recognize and solve potential problems and evaluate effectiveness
Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned
Help to align data management and clinical programming best practices, standards and conventions within the company
Provide leadership, expertise and support to other department members.
Propose and support initiatives for improving efficiency
Actively support to staff learning & development within the company
Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions
Represent the company at professional meetings, webinars or seminars
Train and mentor data management staff, support in development of new training material and provide training to relevant staff
Participate in the interview process for new recruits
Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes
Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System
Assure good communication and relationships with (future) clients
Contribute to and take part in client evaluations and visits
Support in preparation of new proposals and budgets for Data Management services
Contribute to other areas of business as required
Requirements
To be successful you will possess:
Life science, healthcare degree and/or combination of education and experience
Minimum 5 years of relevant work experience as Clinical Data Manager in CRO environment
Minimum 5 years of experience in drug development and/or clinical research
Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements
Good understanding of Medical Terminology
Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA
Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases. Experience in covering all phases of a clinical study (start up, conduct and database lock).
Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation
Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands-on experience implementing these models
Experience in developing data management standards
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Administrative excellence
Attention to detail, strong technical, analytical and problem-solving skills
Strong project management skills
Ability to translate guidelines, rules and regulations in clear and usable recommendations
Ability to simplify complex issues into understandable concepts
Excellent organizational, negotiating and motivational skills
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-BL1
Location: United States
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Looking to take your project management expertise to the next level? Join us as a
Project Manager II (PM II)
and lead the delivery of complex clinical trials that make a meaningful impact for patients worldwide. We are seeking a strategic and execution-focused leader with strong experience managing
Infectious Disease, Immunology & Inflammation, Cell & Gene Therapy, and Neurology
who thrives in a fast-paced, collaborative environment.
About the Role
As a Project Manager II, you will lead with impact and drive global clinical trials from study start-up through final delivery. You’ll oversee cross-functional teams, ensuring studies remain on track, on budget, and compliant with GCP and regulatory requirements while serving as the primary point of contact for sponsors, vendors, and internal stakeholders. With a focus on proactive problem-solving, risk mitigation, and operational excellence, you’ll play a critical role in delivering high-quality clinical programs that exceed client expectations.
Your main responsibilities will include but not limited to:
Driving project success by leading cross-functional teams to deliver clinical trials on time, within scope, and on budget.
Ensuring excellence and compliance by developing and executing project plans aligned with GCP, SOPs, and regulatory standards.
Aligning stakeholders by serving as the primary point of contact for sponsors, vendors, and internal teams.
Optimizing vendor performance through strategic selection, management, and oversight.
Mitigating risks and control budgets by proactively addressing challenges, scope changes, and resource allocation.
Maintaining inspection-ready documentation by leading key meetings and ensuring the Trial Master File and study records are complete.
Requirements
About You
If you are a results-driven Project Manager II with a proven track record of leading complex clinical trials from start-up to closeout. If you thrive in fast-paced environments, excel at aligning teams and stakeholders, and take pride in delivering projects on time, on budget, and with uncompromising quality then this role is for you.
To be successful, we are looking for the following traits and behaviors:
Minimum Bachelor’s degree in life science, healthcare and/or business degree
Minimum 6 years of relevant work experience, specifically experience in drug development and/or clinical research
Minimum 1 year of project management experience, specifically as a clinical project manager
Strong expertise managing the unique operational complexities associated with Infectious Disease, Immunology & Inflammation, Cell & Gene Therapy, and Neurology programs, including oversight of specialized vendors, timelines, safety considerations, and global study execution.
Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
Demonstrates strong financial acumen, administrative excellence and analytical skills
Experience managing all phases of the full-service clinical trial delivery lifecycle (Start-up, Maintenance, Close-out).
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we
SHINE
. Find more information about our values.
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Apply now!
If you are interested in this role, please apply through the button or for more information reach out to Tiffany Wasti at tiffany.wasti@allucent.com
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-Remote #LI-TCW
Location: United States
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.
The
Account Development Manager
is responsible for increasing market awareness, generating leads, and increases Allucent's customer base. This is achieved by a high degree of direct contact with clients including by telephone, by email and direct mail. Account Development (‘inside sales’ division) supports Allucent’s geographically aligned Business Development (BD) team members in reaching annual sales targets. The duties also include assisting in developing and implementing strategies to facilitate long term relationship with new and existing clients.
Location:
United States (all regions); Remote with travel (30-60%)
Responsibilities:
Assist in the generation of new leads and set up meetings with clients who have business to outsource within Allucent’s current and planned service capabilities.
Partner with BD to develop and initiate territory development plan and establish account ownership assignments.
Hold weekly territory outreach planning calls with assigned BD
Identify well aligned potential clients and contacts using defined “ideal account” profiles by using GlobalData, Zymewire and other news resources as triggers for new based outreach
Increase harvest rate by identifying, qualifying and analyzing new account potential, initiating interaction to determine requirements of major pharma and targeted biotech companies.
Identify key stakeholders/decision makers and introduce Allucent differentiators and capabilities resulting in opportunities for Allucent to participate in the request for proposal and bid process.
Using activity and results data create improved outreach messaging in effort to increase client response and interactivity
Use of online tools, software, databases and social media to search, identify and qualify leads
Develop and deploy territory and account strategies that incorporate significant account and industry profiling with pipeline and therapeutic content
Initiate sales process by communication (calls, emails or direct mail), understanding prospective client requirements, introducing services that address their needs and engaging Business Development with prospective clients when ready for face-to-face meetings
Create messaging campaigns with appropriate cadence and follow up follow-up, including informational emails and marketing collateral (such as white papers, case studies, upcoming event notifications, etc.)
Set-up meetings for BD representatives: regionally and at conferences etc. in coordination with Marketing
Provide weekly, monthly and quarterly sales activity reports to review with Line Manager and Business Development executives
Demonstrate an in-depth knowledge of Allucent’s operational capabilities and differentiators
Ensure all activity is recorded in Salesforce
Requirements
Life science, healthcare and/or business degree
Minimum 2 years of relevant work experience, preferably within the CRO/pharmaceutical industry
Clear understanding of clinical trial processes
Basic knowledge of GxP
GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements
Previous Salesforce experience
Excellent New business identification and prospecting skills with a consultative approach
Ability to identify client needs and new business opportunities
Strong interpersonal and social skills to liaise with prospective client’s key decision makers and internal stakeholders
Ability to translate guidelines, rules and regulations in clear and usable recommendations
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-TCW #LI-remote
Location: Amsterdam, Netherlands; Madrid, Spain; Munich, Germany; Paris, France; Bracknell, United Kingdom; Belgrade, Serbia
We have a rare opportunity for a
VP, Quality Assurance
to join our A-team. In this role you will be responsible for leading the strategic vision, operations, and financial health of the Quality organization. You will be responsible for planning, preparation and execution oversight of customer audits/inspections. You will lead approaches for quality KPIs/metrics and other activities in accordance with the standard operating procedures, regulatory guidelines, executed client contract and the clients’ expectations. You will take part in the Allucent Leadership team.
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Key responsibilities:
Lead to identify, develop and implement the business strategy for the Quality department.
Develop and agree upon operating procedures / business processes
Head over (executive and senior) management team meetings
Review audit reports (e.g., process, project, vendor), as applicable
Maintain and develop organizational culture, values and reputation
Report to applicable internal stakeholders on business strategy, planning, results and performance for the Quality department.
Support regulatory authority inspections as needed
Represent Quality organization in key meetings (e.g., Monthly Business Review, Board).
Monitor and assure client satisfaction on existing projects for the Quality department
Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
Requirements
We're looking for someone with:
Life science, healthcare and/or business degree
Minimum 15 years of relevant work experience
Minimum 12 years of experience in drug development and/or clinical research
Thorough knowledge of ICH-GCP (R3), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements
Process oriented
Strong analytical skills
Decision-making capabilities
Critical thinking skills
Management skills including, but not limited to, oversight of teams
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Strong leadership skills
Excellent presentation and networking capabilities
Excellent organizational, negotiating and financial skills
Strong Business Acumen
Benefits
Competitive salaries and a comprehensive benefits package
Departmental Study/Training for furthering professional development
Mentoring opportunities
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our internal employee recognition programs for going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we
SHINE.
find more information about our values.
Apply now!
If you’re ready to bring your passion for clinical development and business growth to Allucent, apply today or reach out to Ariane des Tombe (ariane.destombe@allucent.com ) for more information.
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes
#LI-AdT
Location: Cary, United States
We have a rare opportunity for a
VP, Quality Assurance
to join our A-team. In this role you will be responsible for leading the strategic vision, operations, and financial health of the Quality organization. You will be responsible for planning, preparation and execution oversight of customer audits/inspections. You will lead approaches for quality KPIs/metrics and other activities in accordance with the standard operating procedures, regulatory guidelines, executed client contract and the clients’ expectations. You will take part in the Allucent Leadership team.
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Key responsibilities:
Lead to identify, develop and implement the business strategy for the Quality department.
Develop and agree upon operating procedures / business processes
Head over (executive and senior) management team meetings
Review audit reports (e.g., process, project, vendor), as applicable
Maintain and develop organizational culture, values and reputation
Report to applicable internal stakeholders on business strategy, planning, results and performance for the Quality department.
Support regulatory authority inspections as needed
Represent Quality organization in key meetings (e.g., Monthly Business Review, Board).
Monitor and assure client satisfaction on existing projects for the Quality department
Identify key accounts and maintain strong long-lasting relationships to win new and repeat business
Requirements
We're looking for someone with:
Life science, healthcare and/or business degree
Minimum 15 years of relevant work experience
Minimum 12 years of experience in drug development and/or clinical research
Thorough knowledge of ICH-GCP (R3), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements
Process oriented
Strong analytical skills
Decision-making capabilities
Critical thinking skills
Management skills including, but not limited to, oversight of teams
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Strong leadership skills
Excellent presentation and networking capabilities
Excellent organizational, negotiating and financial skills
Strong Business Acumen
Benefits
Competitive salaries and a comprehensive benefits package
Departmental Study/Training for furthering professional development
Mentoring opportunities
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our internal employee recognition programs for going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Together we
SHINE.
find more information about our values.
Apply now!
If you’re ready to bring your passion for clinical development and business growth to Allucent, apply today or reach out to Ariane des Tombe (ariane.destombe@allucent.com ) for more information.
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes
#LI-AdT
Location: Milan, Italy; Rome, Italy
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote) in Italy! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.
In this role your key tasks will include:
Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
Ensure planned dates are reliable and up to date in CTMS departments/study teams
File documents in the (e)TMF for which they are the document owner
Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner
Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level
Provide relevant documents in compliance with local regulation
Support review of technical, pre-clinical and clinical reports for regulatory submissions
Interact with regulatory authorities
Prepare and compile answers for questions raised by the regulatory agencies and submit the answers
Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate
Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed
Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level
Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation
Interact with IEC/IRB
Prepare and compile answers for questions raised by the IEC/IRB and submit the answers
Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate
Assist in adapting country SIS/ISF to site-specific requirements
Provide country specific requirements to GSCM impacting site contracts’ process
Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study
Negotiate within client approved contract and budget templates and negotiation parameters
Communicate with sites and internal personnel regarding the status of contracts and contract related documents
Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable
Provide the final/draft CTA and site budget for submission, where required
Obtain site signature as well as Sponsor/Allucent signature, as applicable
Keep up to date with applicable local regulations impacting clinical trial contracts
Assist in preparing the site-specific Essential Document Package and sending to sites
Responsible for collection and first review of Essential Documents
Provide the Global Essential Document Reviewer with the collected documents for independent review
Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution
Obtain authorization for the shipment of Investigational Product to the site
Track relevant information and data in CTMS and/or other tracking tools
Requirements
To be successful you will possess:
Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
A thorough understanding of the drug development process
Good oral and written communications skills - fluent in Italian and English.
Attention to detail.
Able to perform well as a team member.
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-BL1
Location: Sofia, Bulgaria
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Start-Up Associate Contractor to join our A-team (hybrid*/remote) for
up to 0.5 Fte
! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.
In this role your key tasks will include:
Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
Ensure planned dates are reliable and up to date in CTMS departments/study teams
File documents in the (e)TMF for which they are the document owner
Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner
Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level
Provide relevant documents in compliance with local regulation
Support review of technical, pre-clinical and clinical reports for regulatory submissions
Interact with regulatory authorities
Prepare and compile answers for questions raised by the regulatory agencies and submit the answers
Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate
Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed
Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level
Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation
Interact with IEC/IRB
Prepare and compile answers for questions raised by the IEC/IRB and submit the answers
Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate
Assist in adapting country SIS/ISF to site-specific requirements
Provide country specific requirements to GSCM impacting site contracts’ process
Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study
Negotiate within client approved contract and budget templates and negotiation parameters
Communicate with sites and internal personnel regarding the status of contracts and contract related documents
Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable
Provide the final/draft CTA and site budget for submission, where required
Obtain site signature as well as Sponsor/Allucent signature, as applicable
Keep up to date with applicable local regulations impacting clinical trial contracts
Assist in preparing the site-specific Essential Document Package and sending to sites
Responsible for collection and first review of Essential Documents
Provide the Global Essential Document Reviewer with the collected documents for independent review
Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution
Obtain authorization for the shipment of Investigational Product to the site
Track relevant information and data in CTMS and/or other tracking tools
Requirements
To be successful you will possess:
Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
More than 5 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
Experience with contract negotiation.
A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
A thorough understanding of the drug development process
Good oral and written communications skills - fluent in Bulgarian and English.
Attention to detail.
Able to perform well as a team member.
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-BL1
Location: United States
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.
The
Sr
.
Director, Business Development
is responsible for managing and leading sales, acquisition and account management from prospective new and existing clients, using ethical sales methods and relationship building to optimize Allucent’s quality of services, business growth, and client satisfaction.
Location:
United States (all regions); Remote with travel (30-60%)
Responsibilities:
Support Leadership by contributing to the identification, development and implementation of the business strategy for BD
Achieve or exceed annual sales targets to drive our company sales goals
Proactively identify, qualify and develop both new and existing clients and business opportunities in assigned territories
Coordinate and drive business opportunities along the sales cycle from lead generation, CDA, RFI/RFP, bid defense, award, through contract execution
Ensure and maintain deep understanding of the market including competitors, clients/leads, industry trends to appropriately sell our services
Maintain frequent personal contact and outreaches with leads and clients via email, calls, meetings, visits, meetings at conferences · Build and foster relationships with key decision-makers of new and existing clients
Obtain in-depth understanding of the client’s organization to match and leverage (changing) client’s needs with our services to gain RFPs
Proactively seek ways to build sales pipeline and grow our company’s client base focused on small and emerging biopharma
Coordinate, drive and host client meetings and bid pursuits
Provide guidance and insights of client needs, wishes and expectations to appropriate leadership, Proposals and Contracts (PAC), Legal teams to ensure winning proposal/bid strategies
Support preparation of proposals
Responsible for contract negotiations and closing of sales
Follow-up lost proposals and bid defenses to gain competitive feedback and areas of improvement for Allucent, both external/internal
Maintain day-to-day sales administration activities in a detailed and timely manner in our Customer Relationship Management (CRM) system Salesforce
Demonstrate a strong work ethic and represent Allucent with high integrity, ethics, honesty, loyalty, and professionalism at all times.
Maintain high professional standards in the communication with clients to build and maintain a good Allucent reputation
Adequately transfer to operational departments upon (verbal) award and signed contracts as per BD Handoff
Collaborate and ensure open communication with operational departments to match clients’ needs and demands with internal Allucent capabilities and offers for change orders and new opportunities
Report sales activities to Manage
Contribute to other areas of business as required.
Requirements
Bachelor’s or Master’s degree in life sciences or business
Minimum 5 years of demonstrated, successful business development experience in the life sciences, pharmaceutical, and/or biotech industries
Proven track record in consistently achieving or exceeding annual sales targets.
Ability to identify client needs and new business opportunities
Strong communication and networking capabilities · Strong presentation skills · Excellent organizational and financial skills
Strong written and verbal communication skills including good command of English language and applicable additional languages for assigned territories
Ability to build a productive territory and qualitative pipeline
Strong prospecting and nurturing skills
Professional presence, outgoing and client focused
Effective at problem solving, strategic thinking and conflict resolution
Ability to work in a fast-paced challenging environment of a growing company
Administrative proficiency
Proficiency with various computer applications such as Word, Excel, and PowerPoint
Ability to use the CRM system Salesforce
Good knowledge of GxP
Understanding of GDPR/HIPAA and applicable (local) regulatory requirements
Benefits
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-Remote #LI-DE1
Location: United States
Bring your monitoring expertise to the forefront of innovation.
We are looking for a
Clinical Research Associate (CRA)
to join our A-team (remote; with travel). As a
CRA
at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. At Allucent we are big enough to deliver and small enough to care. We know all our colleagues by name and work together as a team to make everyone SHINE.
The role
As a
CRA
, you will take the lead on monitoring activities, owning your sites and relationships with investigators. You’ll be the bridge between sponsor and site, ensuring trial integrity while being supported by a collaborative, experienced team. You will be a mentor for junior team members and contribute to grow our success. You will travel throughout the United States.
Therapeutic Areas:
Oncology, Cell & Gene Therapy, and/or Neuroscience
Preferred location:
West Coast, USA
Main responsibilities:
Independently manage all aspects
of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
Ensure compliance
with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
Build strong site relationships
, acting as a primary point of contact and ensuring high-quality data collection.
Identify and resolve site issues
, escalating as needed to maintain trial integrity and patient safety.
Mentor and support junior CRAs
, sharing knowledge and best practices.
Requirements
Who are we looking for:
You’re an experienced CRA / monitor ready to take the next step with a company that truly values your expertise and independence. You thrive in an agile, collaborative environment and want to be part of a team making a real impact.
Preferred Location: West Coast, United States
Therapeutic Areas:Oncology, Cell & Gene Therapy, and/or Neuroscience
Experience leading monitoring activities in complex trials with a minimum of at least 3-5 years’ experience.
Experience in complex therapeutic areas such as cell and gene therapy, radiopharmaceutical preferred.
Strong understanding of ICH-GCP and regulatory guidelines.
Clear and confident communicator in English.
Comfortable working independently and managing priorities.
Willingness to travel throughout the United States, as required.
Effective clinical monitoring skills (all kind of visits mastered)
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our global offices.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-TCW #LI-remote
Location: United States
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a
Board-Certified Neurologist
to join our A-team (remote). As Sr. Medical Director at Allucent, you are responsible for working independently to ensure the medical/clinical and safety integrity and quality of trials conducted by Allucent, serving as the medical monitor contact in study protocols to investigators and study sites team regarding protocol related questions and safety of the subjects enrolled. Experience in
Neurology
is a requirement for this position.
In this role your key tasks will include:
Independently provide medical monitor support to assigned clinical studies, for example answering medical questions from study team and/or site, assist with protocol interpretation and medical review of generated data including but not limited to clinical laboratory data and case report forms as necessary to ensure adherence to the protocol, consistency and scientific validity of the data. When appropriate, and with the necessary support from senior colleagues, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen
Prepare the Medical Monitoring and other relevant plans for assigned studies conducted by Allucent prior to the start of the study and in accordance to deliverables contracted.
Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events
Assist clinical data management with MedDRA and WHO coding in assigned trials
Assist by reviewing clinical study documents for medical consistency and relevance, with support of senior medical team members if needed, including but not limited to the clinical trial protocol (CTP), the Informed Consent (ICF) and clinical study report (CSR) other safety reports (e.g., DSUR, PSUR)
Assist in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) and Dose escalation meetings (DEC)
Attend, participate and present in Kick-Off, Investigators’ meeting, and other relevant meetings in assigned projects, as requested.
Provide 24/7 urgent medical support for medical and safety advice if required
Training of project teams on medical aspects of the trial and therapeutic training as required
Review of Protocol Deviations
Identify study risks and provide input to the Risk plan
Review and understand study medical deliverables laid down in the assigned study’s contract with support of senior colleagues and help track budget spent throughout their assigned study(ies)
Attends and may need to present at major therapeutic conferences and drug development conferences
Assure good communication and relationships with (future) clients
Contribute and take part with support from senior colleagues as needed in client evaluations, visits and bid defenses
Requirements
To be successful you will possess:
MD degree
Must be Board-Certified Neurologist
Experience as Neurologist with Alzheimer's disease and Parkinson's disease, other neurology and psychiatry experience are key assets
Minimum 7-9 years of relevant work experience with solid Neurology expertise
Good knowledge of GxP
Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements understanding
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Access to online soft-skills and technical training via ADP and internal platforms
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-DE #LI-Remote
Location: Cary, United States
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Join our global Payroll and Finance team where you’ll play a key role in managing accurate, timely payroll for employees across the U.S. and Canada. As a
Sr. Payroll Specialist
, you’ll partner closely with Payroll, Finance, and Human Resources to ensure a seamless employee experience while supporting critical payroll processes across the organization.
This role is based in Cary, NC and requires two(2)-three(3) days in office per week
About this role:
As a
Sr. Payroll Specialist
, you’ll play a key role in managing accurate, timely bi-weekly payroll for employees across the U.S. and Canada while overseeing a broad range of payroll activities, including deductions, bonuses, garnishments, tax changes, reconciliations, and employee inquiries. You’ll partner closely with Global Payroll, Finance, Accounting, Human Resources, and external providers to support payroll reporting, audits, benefits plans, and compliance across multiple jurisdictions. This is a hands-on opportunity to take ownership of critical payroll processes while contributing to broader business initiatives.
Requirements
About you:
If you are a detail-oriented payroll professional who takes ownership, thrives in a fast-paced environment, and brings strong judgment when handling sensitive information. As well as a collaborative problem-solver with strong communication skills who can confidently manage complex payroll processes while partnering across Payroll, Finance, HR, and the broader business, this role is for.
To be successful we are looking for the following traits and behaviors:
3–5+ years of hands-on payroll experience
, supporting U.S. and Canadian payroll.
Strong attention to detail and accuracy
, with the ability to manage complex payroll processes, reconciliations, and deadlines.
Experience with ADP Workforce Now
or a similar payroll/HRIS platform.
High level of confidentiality and discretion
when handling sensitive employee and payroll information.
Strong communication and problem-solving skills
, with the ability to collaborate across Payroll, Finance, HR, and other teams in a fast-paced environment.
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for remote/hybrid* working depending on location
Leadership and mentoring opportunities
Participation in our Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Disclaimers:
*Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2-3 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-DE
Location: Belgrade, Serbia; Prague, Czechia; Warsaw, Poland; Bratislava, Slovakia; Budapest, Hungary
The Feasibility Manager (FM) produces and oversees recommendations for country and site selection strategies, as well as enrolment projections and subject recruitment strategies within the Global Study Start-Up and Site Intelligence department.
This position assures the integrity and proper interpretation of used data sources and the resulting strategy provided in feasibility proposals and reports. The FM supports Business Development (BD) and the Allucent Centers of Expertise (ACEs) .
The ACEs are designed, structured, and resourced to deliver comprehensive trial and regulatory strategy; effective patient-focused recruitment plans; and solutions that meet specific needs. The Global Feasibility Manager will play a key role in supporting our ACE heads in winning new business by understanding protocol’s expectations, the mechanism of action of the drug and analysing data to provide strategic feasibility recommendations.
This position reports to the GSSU, Site & Patient Engagement department.
Key Responsibilities:
Provide input to proposals and business development to help build project assumptions, budget, and timelines (including overall recommendations on the countries, number of sites and projected number of patients).
Identify and present regions where the disease is prominent to create an initial country pool to be further refined based on corporate experience, operational capabilities, medical input, and other feasibility considerations
Identify the incidence and prevalence of the disease / syndrome
Analyze competing clinical trial landscape in order to assess study feasibility and identify barriers for enrollment.
Access open source and proprietary databases to determine similar patient populations and or therapeutic classes of drugs under investigation.
Determine whether the countries proposed have comparator drug access/reimbursement. As appropriate, prepare tabular displays of this information for evaluation by the feasibility stakeholder pool.
Represent Allucent’s global or regional expertise by presenting our study footprint in the indication, which may include compiling corporate experience, and expertise in specific indication when needed.
Present and explain feasibility analysis to BD/Clients (e.g. during bid defense meetings), including the process, recommendations and rationale.
Maintain internal libraries and databases related to feasibility
Assure the Feasibility function interfaces effectively with the ACEs and Business Development teams within Allucent
Maintain current knowledge of guidelines and technologies appropriate for functioning in this capacity.
Requirements
Bachelor's Degree in a life sciences field is required. Masters Degree or Ph.D. in Healthcare or Biological Science is preferred. Minimum of 5 years of experience in drug development and/or clinical research; or equivalent combination of education, training, and experience.
Demonstrable experience with analytics involving large datasets.
Previous experience in pre-award feasibility may be a plus.
Some travel for BD meetings attendance (15-20%) may be required.
Skills
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Demonstrated knowledge of government/international databases, open-source databases or more proprietary databases (e.g., PubMed/Medline, ClinicalTrials.gov, Citeline)
Ability to interpret data sources and translate information in clear and usable recommendations
Demonstrated ability to form strong working relationships with other groups within the organization essential to high-level performance in this position
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
You are curious, like using systems, science-centric, and wish to consider a career change ? You have a strategic mindset and you are great at managing your time ? This opportunity may be the perfect fit for you.
The successful candidate will receive the necessary trainings to grow in this role.
Benefits
Benefits of working at Allucent include:
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our
global offices
.
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
#LI-BL1
УдалённоUnited States
Madrid, Spain
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