Allucent

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 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: 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