Location: European Union
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a
Data Manager
on a contractor basis.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
The Data manager will be responsible for leading data management (DM) activities for clinical trials including database set up, study conduct and close-out. The Data manager will work collaboratively with a cross functional team to maintain project timelines and to deliver high quality DM deliverables. Key responsibilities may include, but are not limited to:
Lead Data management activities and ensure study deliverables meet timelines and quality standards.
Review of Clinical research documents (e.g. protocols, Case Report Forms).
Create and review electronic Case Report Form (eCRF) specifications.
Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
Develop edit rules/checks, query logic and query messages.
Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
Create and provide training to the clinical team and sites.
Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
Coordinate the archiving of study databases and related documents
Create Data Transfer Specifications and perform external vendor reconciliation.
Perform SAE reconciliation.
Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.
Qualification
Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or related field or nursing degree.
Atleast 3 years data management and/or related work experience in a pharmaceutical industry.
Working knowledge of Clinical research and clinical trial process and related regulatory requirement and terminology.
Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave, Oracle InForm, OpenClinica and Medrio.
Perform duties in compliance with SOPs, GCP and ICH guidelines.
Ability to prioritize and to adapt quickly in fast-paced and changing industry conditions.
Ability to lead a study or data management team independently.
Proactively drive quality and efficiently to meet timelines and milestones to deliver high quality data management deliverables.
Excellent verbal and written communication skills.
Proficient in the use of Microsoft office(Outlook, word, excel, powerpoint, etc)
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-DNP
Location: United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Senior Statistical Programmer Consultant
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
The
Senior Statistical Programmer Consultant
is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks
Key Responsibilities:
Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
Programs independently with high efficiency and quality.
Writes and/or implements specifications and oversees completeness of relevant documentation.
Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
Ensures compliance with standards and automation usage.
Plans and support team activities and tasks.
Communicates and escalates risks within the assigned studies and/or projects.
Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.
Education and Experience:
Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
Good understanding of the clinical drug development process.
Strong communication skills and coordination skills.
Current knowledge of technical and regulatory requirements relevant for the role
Ability to proactively manage concurrent activities within a project
Proficient ability to influence relevant stakeholders on programming-related items
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #senior#contract
Location: Canada
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Formula/Product Compliance Associate Consultant
with
HYBRID
option in
CANADA
for
12 months CONTRACT
, to join one of our major consumer products clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.
We are currently seeking a
Formula/Product Compliance Associate Consultant
to support regulatory compliance for cosmetic products across global markets.
Position Summary:
The Formula/Product Compliance Associate will be responsible for ensuring that all cosmetic formulas and finished products comply with relevant global regulations. This role involves reviewing ingredients, formulas, and raw material documentation to ensure products meet applicable regulatory, safety, and brand standards.
Hybrid Model: 2 To 3 days a week
Location:
351 Hillmount Road, Markham, ON L6C 2S3
Key Responsibilities:
• Review cosmetic product formulations for compliance with international cosmetic regulations (e.g., US, EU, Canada, APAC, LATAM).
• Evaluate ingredients against global regulatory lists (restricted/prohibited substances, concentration limits, etc.).
• Maintain and update formula and ingredient databases with regulatory and safety data.
• Support the preparation of Product Information Files (PIFs), Safety Assessments, and regulatory dossiers.
• Collaborate with R&D, Product Development, Quality, and Regulatory Affairs teams to support product launch timelines.
• Monitor changes in regulatory requirements and proactively communicate updates to relevant stakeholders.
• Maintain accurate and organized documentation for audits and regulatory inquiries.
Qualifications:
• Bachelor’s degree in a technical field such as Life Sciences, Chemistry, Biology, Biochemistry, or a related Physical Science.
• Minimum of 1 year of relevant experience in regulatory affairs, product compliance, or cosmetic formulation.
• Familiarity with cosmetic regulatory frameworks (e.g., EU Cosmetic Regulation, U.S. FDA Cosmetic requirements, INCI nomenclature).
• Detail-oriented with strong organizational and analytical skills.
• Effective verbal and written communication skills.
• Proficiency in Microsoft Office Suite; experience with regulatory databases a plus.
Preferred Qualifications:
• Experience supporting global cosmetic regulatory submissions (e.g., EU CPNP, UK SCPN, US MoCRA).
• Knowledge of raw material and formula compliance systems or databases.
• Exposure to claims review and product labeling compliance.
#LI-PB1 #LI-Hybrid #Contract
AI:
Our hiring process includes AI screening for keywords and minimum qualifications. Recruiters review all results.
Vacancy:
This posting is for an existing vacancy.
Open Date: 22/10/2026
Close Date: 06/12/2026
ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.
We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.
The base salary pay range represents the anticipated low and high range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Canada Pay Range
$20
—
$23 USD
Location: Yerevan, Armenia
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an
Associate, Medical Writing (MD)
on a permanent basis.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
The Medical Writer acts as a team member supporting and executing the creation and updating of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance Reports (SSCP), State of the Art Reviews (SOA) and Systematic Literature Reviews (LRR) for their assigned therapeutic area within Depuy Synthes.
Main Job Tasks and Responsibilities:
Performs tasks according to the assigned medical writing activities including systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), State of the Art (SOA), Post-Market Surveillance (PMS) including Periodic Safety Update Reports (PSUR), and Premarket Approval (PMA) Food and Drug Administration (FDA) Reports, including Humanitarian Device Exemption (HDE), Investigative Device Exemption (IDE) Reports, and Health Economics and Market Access (HEMA) research. The specific tasks are to be determined based on the assigned role in the project.
Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues are encountered impacting the delivery schedule.
Ensures error free and acceptable quality of assigned deliverables.
Responsible for ensuring training compliance and timesheet compliance.
Ensures that all assigned goals (e.g., utilization and efficiency) are met as per set standards for the performance year.
Follows and complies with the Company’s Code of Conduct, Policies, and Procedures.
Responsible for confidentiality, integrity, availability, and safeguarding of data.
Responsible for reporting of security incidents and PIMS breaches as applicable.
Complies with company QMS, ISMS, and PIMS requirements and applicable regulatory requirements.
Demonstrates adherence and compliance to PIMS/GDPR requirements as follows: data processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner.
Proficiency in oral and written English language.
Proficiency in Microsoft Office Suites (e.g. Word, Excel, PPT, SharePoint).
Education and Experience:
Minimum bachelor’s degree in any life sciences field and at least 1 year of
experience in medical writing, or any related field as applicable, OR
Advanced/Post graduate degree in Medicine or life science (i.e. Master’s in
Public Health) with any professional experience.
Can work in a diverse team environment.
Good analytical and comprehension skills.
Proficient in time management and can work with minimal supervision.
Our Benefits:
Flexible Working Hours
Team events and end of year party
Employee satisfaction survey - your feedback is important for continuous improvement
Health Insurance
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Location: United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Senior Statistical Programmer Consultant
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
We are seeking an experienced
Senior Statistical Programmer with hands-on experience in Gene Therapy clinical trials
to lead study-level statistical programming activities. The ideal candidate will have strong SAS programming expertise, a solid understanding of clinical trial data and regulatory requirements, and the ability to independently manage programming deliverables in collaboration with Biostatisticians and cross-functional teams.
Experience in Gene Therapy clinical development is essential. Experience in Oncology or Internal Medicine is also valuable.
Key Responsibilities
Lead statistical programming activities for Gene Therapy clinical trials from study start-up through database lock, analysis, and reporting.
Develop, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs).
Collaborate with Biostatisticians to interpret study protocols, Statistical Analysis Plans (SAPs), and programming specifications.
Develop and validate clinical datasets and statistical outputs for safety and efficacy analyses.
Support interim and final analyses, database lock activities, and Clinical Study Report preparation.
Ensure programming deliverables comply with CDISC standards and applicable regulatory requirements.
Perform independent validation and quality control of datasets, TLFs, and other programming outputs.
Support regulatory submissions and address programming-related questions from internal and external stakeholders.
Manage study-level programming timelines, deliverables, and quality expectations.
Identify and resolve complex programming issues and proactively communicate risks.
Provide technical guidance and mentorship to other Statistical Programmers.
Participate in client-facing meetings and collaborate with cross-functional project teams.
Required Qualifications
Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
Significant experience in clinical trial statistical programming within a pharmaceutical, biotechnology, or CRO environment.
Hands-on experience supporting Gene Therapy clinical trials is required.
Strong proficiency in SAS programming.
Strong knowledge of CDISC standards, including SDTM and ADaM.
Experience developing and validating clinical trial TLFs.
Ability to independently lead study-level programming activities.
Understanding of clinical trial processes, statistical analysis, and regulatory reporting.
Excellent analytical, communication, and problem-solving skills.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #senior#contract
Location: United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Senior Statistical Programmer Consultant
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
We are seeking an experienced
Senior Statistical Programmer
with strong expertise in clinical trial programming and a solid background in
oncology
. The successful candidate will be capable of independently leading statistical programming activities across clinical studies, partnering closely with statisticians, clinical teams, and other cross-functional stakeholders.
This role requires strong technical expertise in
SAS programming, CDISC standards, and clinical trial reporting
, along with the ability to take ownership of programming deliverables and provide guidance to junior team members.
Key Responsibilities
Lead statistical programming activities for clinical studies within the
oncology therapeutic area
, from study start-up through database lock, analysis, and reporting.
Develop, review, and maintain high-quality SAS programs for
SDTM, ADaM, Tables, Listings, and Figures (TLFs)
.
Lead programming activities for interim and final analyses, including complex efficacy and safety analyses.
Work closely with Biostatisticians to understand statistical analysis plans, programming specifications, and study requirements.
Develop and review programming specifications and ensure consistency with study protocols, SAPs, and statistical methodology.
Support the creation and validation of
CDISC-compliant SDTM and ADaM datasets
.
Generate and validate TLFs for clinical study reports, regulatory submissions, and other clinical deliverables.
Perform independent programming validation and quality control of statistical outputs and datasets.
Support submission-related activities and respond to programming and data-related queries from cross-functional and regulatory teams.
Identify potential programming issues and proactively communicate risks, timelines, and solutions to project stakeholders.
Coordinate programming activities across studies and ensure deliverables are completed within agreed timelines and quality standards.
Provide technical guidance and mentorship to Statistical Programmers and other programming team members.
Participate in client/project meetings and effectively communicate technical information to both technical and non-technical stakeholders.
Required Qualifications
Bachelor's or Master's degree in
Statistics, Biostatistics, Mathematics, Computer Science, or a related field
.
Strong experience in
clinical trial statistical programming
, preferably within a CRO, pharmaceutical, or biotechnology environment.
Significant experience working on
oncology clinical trials
.
Basic or working knowledge of R programming is preferred.
Experience supporting regulatory submissions
Strong proficiency in
SAS programming
, including Base SAS and relevant SAS procedures used for clinical trial reporting.
Strong knowledge of
CDISC standards
, particularly SDTM and ADaM.
Experience developing and validating
TLFs
for clinical trials.
Experience working with complex clinical trial data and supporting statistical analyses.
Ability to independently manage programming deliverables and lead study-level programming activities.
Strong understanding of clinical development processes, including protocols, SAPs, datasets, TLFs, and clinical study reports.
Excellent communication, organizational, problem-solving, and collaboration skills.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #senior#contract
Location: United States
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a
Senior/
Principal Statistician
to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
SUMMARY
The contractor will provide statistical expertise and operational support for oncology clinical trial projects, with responsibility for ensuring the accuracy, quality, and reproducibility of statistical deliverables. The role requires strong oncology clinical trial experience, working knowledge of CDISC standards, and the ability to collaborate effectively with internal study teams and relevant functional partners, as applicable.
Key Responsibilities
Support statistical analyses of oncology endpoints, including time-to-event and response-based endpoints.
Perform event projections to estimate the timing of planned event-driven analyses.
Review and provide feedback on SDTM and ADaM specifications, tables, listings, figures, statistical analysis plans, protocol amendments, and relevant study documentation.
Conduct routine study data review to identify inconsistencies, missing data, or other issues that may affect analysis or interpretation.
Validate statistical outputs and provide documentation supporting reproducibility and quality control.
Required Skills and Experience
Demonstrated experience supporting Phase 2 and Phase 3 oncology clinical trials, including event-driven and response-based endpoints.
Experience reviewing clinical trial data to identify inconsistencies, missing data, unexpected patterns, or issues requiring follow-up.
Ability to document review findings, assumptions, queries, and follow-up items clearly and track issues through resolution.
Working knowledge of CDISC standards, including SDTM and ADaM.
Strong written communication skills, including the ability to summarize findings, recommendations, and data issues for study team review.
Strong analytical skills and a methodical approach to data review, statistical output review, and issue identification.
Ability to collaborate with study teams, programming teams, and relevant functional partners to support timely resolution of data and analysis-related questions.
Solid understanding of statistical analysis methodology and principles of experimental design.
Proficiency with statistical programming and data processing software, such as SAS and/or R.
Education
PhD or equivalent degree in statistics, biostatistics, or a related discipline with at least 3 years of relevant work experience; or Master’s degree with at least 6 years of relevant work experience.
Work Expectations
The contractor is expected to be available during core U.S. business hours, generally 9:00 a.m.–3:00 p.m. Eastern Time, to interact with U.S.-based study teams.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-DNP
Location: Bengaluru, Karnataka, India
Responsibilities:
Supports UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark products across the product portfolio.
Supports the team with regulatory strategies (local and regional) that are in line with the business plan
Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate. For example, but not limited to:
Prepares and compiles regulatory submissions, response to questions, renewals, post submission/approval activities (including relevant updates to external websites such as emc, medicines.ie and In-Demand)
Supports ad hoc projects (e.g., compliance reviews, audit preparation etc.)
Signs off on packaging material, leaflets, and SmPCs (as appropriate)
Supports the compilation of the Northern Cluster team metrics for the EMEA biannual metrics report
Supports all regulatory activities in Malta
Ensures regulatory compliance within the department to include:
The maintenance of global, regional, and local databases
Adherence to processes, SOPs, work instructions, and job aids
Updates to relevant local and global databases to track current product information
Supports team with Calls for Information (CFI) and assist in any Pharmacovigilance- related activities within the Northern Cluster, which may include:
Receiving and monitoring responses to CFIs through liaison with UK and EAME colleagues
Ensuring responses are submitted in a timely manner and that they are in line with standard procedures and metrics established by the VP Regulatory Affairs in European Regulatory
Provide support and responses to ad hoc requests received from UK PV group or Global Reg Med Mailbox
Supports the team with regulatory activities for National and/or European procedures (Decentralized, Mutual Recognition) as appropriate.
Ensures regulatory compliance within the department
Experience/Qualifications:
Bachelor's/Master's degree in Life Science/Pharma
Minimum of 5 ~ 8 years of relevant work experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience of CMC, Quality, or Regulatory Operations.
Location: Pasig, Philippines
Purpose:
The
Senior Accountant
overseas and coordinates all aspects of financial operations within the company, including financial reporting, regulatory compliance, and guiding his/her subordinates to achieve Finance goals.
Responsibilities:
Preparation of Financial Reports
FS Sched
Variance Analysis
Check/Review task/reports of subordinates
Check of Vouchers and corresponding attachments
Reports & FS Schedules
Filing to Government agencies
New Joiner
Finance Orientation
Opening of BDO payroll account
AR
IC Recon
AR schedule
Fixed Assets
Monthly Depreciation
FA schedule
FA for disposal - monitoring
General Accounting
Liquidation of CA
Filing of quarterly Income Tax Return
Bank Recon
Skills and Qualifications:
Graduate of Bachelor's Degree in Accountancy
With at least three (3) years of experience in a leadership role
With five (5) or more years of experience in General Accounting
With hands-on experience in Accounts Receivable (AR) and Accounts Payable (AP) processes
Knowledgeable in Taxation, including tax compliance, filing, and reporting requirements
Experienced in preparing Financial Reports and Financial Statements in accordance with accounting standards
CPA License is an advantage
Good Communication Skills
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
Location: United Kingdom
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking an experienced
Senior/Principal Statistician
Consultant
to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development.
Key Responsibilities
Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials.
Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies.
Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation.
Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance.
Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA.
Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams.
Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans.
Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges.
Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents.
Identify statistical risks and recommend appropriate solutions throughout the clinical development process.
Provide technical guidance and mentorship to statisticians and other team members, as appropriate.
Required Qualifications and Experience
PhD in Statistics, Biostatistics, or a related quantitative discipline; a Master's degree with substantial relevant experience may also be considered.
Significant experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.
Strong knowledge of clinical trial design, statistical inference, sample size determination, power calculations, and statistical analysis methodologies.
Proven experience developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports.
Familiarity with regulatory requirements and guidance applicable to clinical development and statistical analyses.
Experience supporting clinical development programs in
oncology, rare diseases, and/or neuroscience.
Experience supporting regulatory submissions and health authority interactions.
Experience with complex clinical trial designs and advanced statistical methodologies.
Proficiency in statistical programming tools such as SAS and/or R.
Strong analytical, problem-solving, communication, and stakeholder-management skills.
Ability to work independently and collaborate effectively with global cross-functional teams.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #contract
Location: European Union
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking an experienced
Senior/Principal Statistician
Consultant
to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development.
Key Responsibilities
Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials.
Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies.
Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation.
Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance.
Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA.
Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams.
Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans.
Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges.
Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents.
Identify statistical risks and recommend appropriate solutions throughout the clinical development process.
Provide technical guidance and mentorship to statisticians and other team members, as appropriate.
Required Qualifications and Experience
PhD in Statistics, Biostatistics, or a related quantitative discipline; a Master's degree with substantial relevant experience may also be considered.
Significant experience in biostatistics within the pharmaceutical, biotechnology, or clinical research industry.
Strong knowledge of clinical trial design, statistical inference, sample size determination, power calculations, and statistical analysis methodologies.
Proven experience developing and reviewing statistical analysis plans, clinical study protocols, and clinical study reports.
Familiarity with regulatory requirements and guidance applicable to clinical development and statistical analyses.
Experience supporting clinical development programs in
oncology, rare diseases, and/or neuroscience.
Experience supporting regulatory submissions and health authority interactions.
Experience with complex clinical trial designs and advanced statistical methodologies.
Proficiency in statistical programming tools such as SAS and/or R.
Strong analytical, problem-solving, communication, and stakeholder-management skills.
Ability to work independently and collaborate effectively with global cross-functional teams.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #contract
Location: United Kingdom
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
We are building our talent pipeline for 2027 and expect to have multiple opportunities throughout the year for experienced professionals in Clinical Statistical Programming at the Senior and Principal level. We anticipate hiring for up to 20 positions during calendar year 2027, with openings becoming available at different times based on client demand and business growth.
The
Senior/Principal Statistical Programmer
is responsible for serving as a technical and study programming lead across multiple compounds and/or studies within the Statistical Programming function, supporting Ipsen’s assets within a specific therapeutic area such as
Oncology, Rare Disease, or Neuroscience
.
The role requires strong hands-on statistical programming expertise, study leadership, and technical knowledge to ensure the quality, consistency, and timely delivery of statistical programming activities. The programmer will work closely with statisticians, clinical teams, data management, and other cross-functional stakeholders and may also provide technical oversight of outsourced programming activities.
Main Responsibilities & Technical Competencies
Serve as a
lead statistical programmer
for multiple studies and/or compounds, ensuring high-quality and timely delivery of statistical programming activities.
Lead and execute statistical programming activities across clinical trials, from study start-up through database lock, reporting, and regulatory submission.
Ensure consistency, quality, and executional excellence across programming deliverables for assigned studies.
Support programming activities for
global regulatory submissions
and responses to health authority questions.
Provide technical oversight and guidance for outsourced statistical programming activities, ensuring deliverables meet required quality, budget, and timeline expectations.
Develop, review, and validate high-quality statistical programming deliverables, including
tables, listings, figures (TLFs), SDTM/ADaM datasets, and associated documentation such as Define-XML
.
Provide technical expertise in
SAS programming
, including development, QC/validation, and documentation of statistical programs.
Contribute to the development, implementation, and continuous improvement of
SAS programming standards, SOPs, work instructions, and best practices
.
Ensure study-related programming documentation is maintained in accordance with Ipsen processes and is inspection/audit ready.
Collaborate with statisticians and cross-functional teams to understand complex study designs, endpoints, and analysis requirements and translate them into robust programming solutions.
Provide
technical guidance and mentoring to other statistical programmers
and contribute to the development of programming capabilities within the organization.
Identify opportunities to improve programming processes, adopt innovative and efficient approaches, and support evolving and complex study design methodologies.
Act as a
subject matter expert
in statistical programming and contribute to technical decision-making within assigned studies and therapeutic areas.
Behavioural Competencies Required
Collaborates effectively across functions and organizational boundaries.
Communicates clearly with both technical and non-technical stakeholders.
Proactively seeks relevant stakeholder input and expertise to support effective decision-making.
Takes ownership and accountability for decisions, actions, successes, and challenges.
Demonstrates strong planning and organizational skills, effectively managing priorities, resources, and timelines.
Maintains a strong focus on quality, compliance, and timely execution.
Demonstrates a proactive approach to identifying risks, resolving issues, and driving continuous improvement.
Supports and coaches colleagues by sharing technical knowledge and best practices.
Knowledge & Experience
Strong proficiency in
SAS programming
within a pharmaceutical, biotechnology, or CRO environment.
Strong understanding of
CDISC standards
, including SDTM and ADaM.
Hands-on experience with
SDTM and ADaM specification, development, and programming
.
Strong experience in
TFL programming and reporting
.
Experience supporting clinical trial reporting and/or regulatory submissions.
Experience working with complex clinical trial data and study designs.
Ability to provide technical leadership and independently manage programming activities across multiple studies.
8+ years of statistical programming experience
in a pharmaceutical, biotechnology, or CRO environment supporting clinical development.
Experience in one or more of the following therapeutic areas is preferred:
Oncology, Rare Disease, or Neuroscience
.
Knowledge & Experience (preferred)
R or other packages are desired;
Understand clinical data flow. Experience in NDA/sNDA submission is desired.
Education / Certifications (essential)
Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline
Language(s) (essential)
English
Language(s) (preferred)
French
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #Contract
Location: European Union
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
We are building our talent pipeline for 2027 and expect to have multiple opportunities throughout the year for experienced professionals in Clinical Statistical Programming at the Senior and Principal level. We anticipate hiring for up to 20 positions during calendar year 2027, with openings becoming available at different times based on client demand and business growth.
The
Senior/Principal Statistical Programmer
is responsible for serving as a technical and study programming lead across multiple compounds and/or studies within the Statistical Programming function, supporting Ipsen’s assets within a specific therapeutic area such as
Oncology, Rare Disease, or Neuroscience
.
The role requires strong hands-on statistical programming expertise, study leadership, and technical knowledge to ensure the quality, consistency, and timely delivery of statistical programming activities. The programmer will work closely with statisticians, clinical teams, data management, and other cross-functional stakeholders and may also provide technical oversight of outsourced programming activities.
Main Responsibilities & Technical Competencies
Serve as a
lead statistical programmer
for multiple studies and/or compounds, ensuring high-quality and timely delivery of statistical programming activities.
Lead and execute statistical programming activities across clinical trials, from study start-up through database lock, reporting, and regulatory submission.
Ensure consistency, quality, and executional excellence across programming deliverables for assigned studies.
Support programming activities for
global regulatory submissions
and responses to health authority questions.
Provide technical oversight and guidance for outsourced statistical programming activities, ensuring deliverables meet required quality, budget, and timeline expectations.
Develop, review, and validate high-quality statistical programming deliverables, including
tables, listings, figures (TLFs), SDTM/ADaM datasets, and associated documentation such as Define-XML
.
Provide technical expertise in
SAS programming
, including development, QC/validation, and documentation of statistical programs.
Contribute to the development, implementation, and continuous improvement of
SAS programming standards, SOPs, work instructions, and best practices
.
Ensure study-related programming documentation is maintained in accordance with Ipsen processes and is inspection/audit ready.
Collaborate with statisticians and cross-functional teams to understand complex study designs, endpoints, and analysis requirements and translate them into robust programming solutions.
Provide
technical guidance and mentoring to other statistical programmers
and contribute to the development of programming capabilities within the organization.
Identify opportunities to improve programming processes, adopt innovative and efficient approaches, and support evolving and complex study design methodologies.
Act as a
subject matter expert
in statistical programming and contribute to technical decision-making within assigned studies and therapeutic areas.
Behavioural Competencies Required
Collaborates effectively across functions and organizational boundaries.
Communicates clearly with both technical and non-technical stakeholders.
Proactively seeks relevant stakeholder input and expertise to support effective decision-making.
Takes ownership and accountability for decisions, actions, successes, and challenges.
Demonstrates strong planning and organizational skills, effectively managing priorities, resources, and timelines.
Maintains a strong focus on quality, compliance, and timely execution.
Demonstrates a proactive approach to identifying risks, resolving issues, and driving continuous improvement.
Supports and coaches colleagues by sharing technical knowledge and best practices.
Knowledge & Experience
Strong proficiency in
SAS programming
within a pharmaceutical, biotechnology, or CRO environment.
Strong understanding of
CDISC standards
, including SDTM and ADaM.
Hands-on experience with
SDTM and ADaM specification, development, and programming
.
Strong experience in
TFL programming and reporting
.
Experience supporting clinical trial reporting and/or regulatory submissions.
Experience working with complex clinical trial data and study designs.
Ability to provide technical leadership and independently manage programming activities across multiple studies.
8+ years of statistical programming experience
in a pharmaceutical, biotechnology, or CRO environment supporting clinical development.
Experience in one or more of the following therapeutic areas is preferred:
Oncology, Rare Disease, or Neuroscience
.
Knowledge & Experience (preferred)
R or other packages are desired;
Understand clinical data flow. Experience in NDA/sNDA submission is desired.
Education / Certifications (essential)
Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline
Language(s) (essential)
English
Language(s) (preferred)
French
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #LI-Principal #Contract
Location: Canada
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Sr. Regulatory Affairs Associate – CONSULTANT
for 12 months Contract with possibility of extension
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
About the Role
J
ob Title:
Sr. Regulatory Affairs Associate – CONSULTANT
Responsibilities:
Regulatory Affairs Associate will actively collaborate with the Company’s regulatory project team to review, update, and create Technical Documents (TDs) in accordance with EU MDR and other applicable regulatory requirements. The high-level activities may include but are not limited to:
Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements
Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
Draft, create or update TDs in collaboration with Platform RA SME.
Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files
Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders.
Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages
Perform Quality Control checks per Company’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc., Verify TD documents are approved and contain the most recent revision(s)
Work with the cross functional teams and Company’s local affiliates to obtain necessary supporting documents
Respond to inquiries from the Company’s local affiliates and proactively notify and coordinate with cross-functional teams including management any health authority–related questions or requests
Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required
Attend meetings and communicate with the project team as appropriate
Routinely communicate with regulatory management team regarding project status and deliverables
Support other regulatory activities as assigned
Minimum Requirements
:
Bachelor’s degree (life sciences preferred)
Minimum of 2 years of working experience in Regulatory Affairs focused on EU MDR
Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory
Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint)
Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
Strong organizational skills including attention to detail, good planning and communication skills are required
Strong written and verbal English communication skills required.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-PB1 #LI-Remote #Contract
AI:
Our hiring process includes AI screening for keywords and minimum qualifications. Recruiters review all results.
Vacancy:
This posting is for an existing vacancy.
Open Date: 07/10/2026
Close Date: 21/11/2026
The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following & delete these instructions):
ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.
We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.
The base salary pay range represents the anticipated low and high range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Canada Pay Range
$40
—
$44 CAD
Location: Mexico
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a
Sr. Regulatory Affairs Associate – CONSULTANT
for 12 months Contract with possibility of extension
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
About the Role
J
ob Title:
Sr. Regulatory Affairs Associate – CONSULTANT
Responsibilities:
Regulatory Affairs Associate will actively collaborate with the Company’s regulatory project team to review, update, and create Technical Documents (TDs) in accordance with EU MDR and other applicable regulatory requirements. The high-level activities may include but are not limited to:
Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements
Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
Draft, create or update TDs in collaboration with Platform RA SME.
Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files
Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders.
Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages
Perform Quality Control checks per Company’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc., Verify TD documents are approved and contain the most recent revision(s)
Work with the cross functional teams and Company’s local affiliates to obtain necessary supporting documents
Respond to inquiries from the Company’s local affiliates and proactively notify and coordinate with cross-functional teams including management any health authority–related questions or requests
Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required
Attend meetings and communicate with the project team as appropriate
Routinely communicate with regulatory management team regarding project status and deliverables
Support other regulatory activities as assigned
Minimum Requirements
:
Bachelor’s degree (life sciences preferred)
Minimum of 2 years of working experience in Regulatory Affairs focused on EU MDR
Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory
Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint)
Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
Strong organizational skills including attention to detail, good planning and communication skills are required
Strong written and verbal English communication skills required.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-PB1 #LI-Remote #Contract
Location: Romania
ClinChoice is a global full-service CRO recognized for its commitment to professional development, strong work-life balance, and a collaborative, quality-driven “one-team” culture. We are currently seeking a Senior Clinical Project Manager to support projects across pharmaceutical, biotechnology, medical device, and consumer health clients, ranging from emerging companies to large global organizations.
In this role, you will lead cross-functional teams and oversee the execution of complex clinical trials, ensuring successful delivery in accordance with contractual commitments, SOPs, ICH-GCP guidelines, and applicable regulatory requirements.
Qualified candidates will have 8+ years of clinical project management experience, including prior experience within a CRO environment. Experience managing complex studies (such as respiratory or rare disease) and/or general medicine studies is required.
This is a permanent remote opportunity, in Romania. Please note that you must have CRO experience to be considered.
Join our global team and help improve peoples' lives!
Main Job Tasks and Responsibilities:
Manage and coordinate complex clinical projects.
Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.).
Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.
Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.
Knowledgeable in the application process for clinical studies, in force in the country/ies of work.
Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.).
May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.
Assure the proper timelines of the assigned projects.
Manage the budget for the project.
Monitor the workload and the performance of the project team.
Plan and monitor the tasks of the team in the specific areas.
Coordinate the Clinical Research Associates and Clinical Monitors activity.
Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities.
Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).
Collaborate with the CTAs in archiving activities.
Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.
Deliver project specific trainings.
Organize and participate in Monitor and Investigator Meetings.
Organize or take part in the periodic project update meetings.
Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.
Inform the Project Director/Leader about any issues.
Perform co-monitoring visits for the assigned clinical projects as necessary.
Act as a tutor for Project Coordinators and Project Manager I.
Maintain relationships with the Sponsor, including providing project updates.
Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit.
Collaborate in complying and enforcing Company procedures.
Education, Experience and Skills:
Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Eight (8) years (at least) of clinical research experience in Project Management.
Previous experience managing respiratory, rare disease, general medicines and/or GPL1 studies is required.
Previous CRA experience is highly desirable.
Previous CRO experience is required.
Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
Prior experience in electronic data capture preferred.
Fluent in English.
Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words:
Senior Project Manager, Senior Clinical Project Manager, Senior Study Manager, Senior Clinical Trial Manager, Study Management, Project Management, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Study Management, Project Leader, Project Lead, complex clinical trials, oncology, respiratory, CRO, Contract Research Organization
#LI-VH1 #LI-Senior #LI-FULLTIME
Location: Mississauga, Ontario, Canada
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a
Senior Statistical Programmer
to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking a highly skilled
Senior Statistical Programmer
to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Main Job Tasks
The
Senior Statistical Programmer
is a delivery-focused role responsible for leading and supporting aspects of the programming effort to deliver technical programming and information components of a project. The position requires strong technical skills, thorough knowledge of the industry, and
demonstrated experience leading statistical programming activities and providing technical guidance to other programmers
. The individual should be able to independently perform programming tasks, oversee programming deliverables, and effectively collaborate with cross-functional teams and external vendors.
Responsibilities
Programing for clinical trials:
Program and validate derived datasets, tables, figures, listings. Process data from the external sources.
Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations.
Oversee programing work/deliverables from CROs.
Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages.
Electronic submissions:
Program and validate CDISC compliant deliveries for the electronic submissions.
Support in the creation of supporting documentation for submissions.
Project Management:
Ensure programming deliverables are on time and of high quality.
Help managing internal contractors and external vendors.
Standards and Guidelines:
Participate in development of departmental working instructions and guidelines.
Help in creation of enhanced functions/macros and utilities.
Qualification & Experience
Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline.
BS with more than 5 or MS with 3 years of experience in statistical programming (SAS, R) in the pharmaceutical industry.
Working knowledge of SAS and its various components.
Knowledge of R programming in clinical trials
Familiarity of the drug development process.
Strong SAS and SAS Macro language skills.
R programming skils in clinical trials
Strong knowledge of industry standards.
Ability to work on data integrations (ISS and ISE).
Strong oral and written communication skills. Ability to communicate details of the analysis to other team members with less technical experience.
Open Date: 9/29/2026
Close Date: 11/23/2026
ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.
We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.
#LI-TT1 #LI-Remote #senior #permanent
The base salary pay range represents the anticipated low and high range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Canada Pay Range
$80,000
—
$95,000 CAD
Location: Bengaluru, India
Primary Responsibilities:
Works closely with hiring managers to understand the requirements of each assigned role and creates the requisition in the Applicant Tracking System.
Identifies, attracts, and engages potential candidates using various channels and methods to find individuals who meet the qualifications and requirements of the assigned open jobs.
Manages job postings for assigned roles through various job portals, career sites, social media, and networking tools.
Reviews resumes and applications to identify qualified candidates who meet the hiring criteria.
Conducts initial phone screens, in-person interviews or virtual interviews to assess candidates' qualifications and suitability for the role
Ensures that all mandatory information and documentation is entered and uploaded into the Applicant Tracking System.
Loads and tracks open roles in the Applicant Tracking System.
Manages the Applicant Tracking system by cleaning and updating the records based on the reporting/metrics requirements.
Proactively identifies and recruits passive job seekers.
Develops and retains relationships with candidates and referrals.
Builds and maintains a comprehensive candidate pipeline that addresses all/any resource needs.
Builds strong strategic relationships with hiring managers and teams, handle a diverse set of roles/positions, and able to manage competing priorities.
Maintain confidentiality of HR information.
Other TA related projects/tasks as assigned.
Candidate Profile:
Bachelor’s / Master's degree required or a combination of education, experience, and/or skills with 3-5 years of experience in candidate recruiting.
Experience working with Agencies and diverse Recruiting partners to identify best fit candidates.
Proficient in MS Office (Word, Excel, Outlook).
Strong recruiting experience within Life Sciences industry is required.
Good verbal and written language skills in English.
Ability to be discreet and handle confidential and sensitive information.
Strong interpersonal, negotiation, and communication skills.
Ability to work under tight timelines.
seniorBengaluru, India
seniorUnited States
Canada
Не хотите искать каждый день?
Настройте подбор один раз, и подходящие вакансии будут сами приходить в Telegram.
Настройте подбор, и подходящие вакансии будут приходить в Telegram.
