Supports electronic Trial Master File setup, maintenance, quality checks, reporting, archival, and audit readiness. The role manages clinical study documentation, trackers, scanning, filing, document reviews, and compliance with SOPs, GCP, ICH guidelines, privacy standards, and sponsor requirements. It also coordinates document retrieval and finalization across stakeholders, assists with staff training, and performs proofreading and administrative tasks.
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.
Role Objectives:
The WEP Clinical Documentation Specialist is responsible for supporting the management of
program documentation in accordance with Standard Operating Procedures (SOPs), Good
Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and projectspecific Trial Master File (TMF) plans.
program documentation in accordance with Standard Operating Procedures (SOPs), Good
Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and projectspecific Trial Master File (TMF) plans.
The Ideal Candidate:
- Detail-oriented
- Highly Organized
- Adaptable
- Team Player
What You'll Do:
- Support electronic Trial Master File (eTMF) setup, maintenance, and closeout in accordance with WEP Clinical processes, sponsor requirements, and applicable regulations.
- Collaborate with internal project teams to ensure timely retrieval, filing, and availability of essential documents.
- Maintain systems and tools used to evaluate, track, and transmit TMF documents.
- Conduct detailed quality checks (QC) and content reviews of eTMF documents at defined time points, including any required paper originals.
- Generate and provide TMF metrics and content reports to project management teams and leadership, as assigned.
- Scan (or coordinate scanning), label, upload, and appropriately file documents to ensure traceability and accessibility.
- Ensure adherence to WEP Clinical privacy, security, and document retention standards.
- Support TMF archival activities and long-term document storage strategies following project closeout.
- Assist with internal and external TMF audits to ensure compliance with SOPs, policies, FDA, and ICH GCP guidelines.
- Maintain study status trackers and other project documentation tools.
- Label, sort, categorize, and retrieve documents; assist with training staff on documentation practices and perform proofreading and administrative tasks as needed.
What You'll Need:
- Bachelor’s degree preferred
- 1 - 2 years of experience in order processing and documentation management systems preferred
- Familiarity with clinical study documentation, including QC, SOPs, GCP guidelines, and archiving best practices
- Experience with clinical trial electronic databases preferred
- Proven ability to meet quality and timeline objectives
- Strong computer skills, including proficiency in Microsoft Office
- Skilled in formatting and publishing documents, and maintaining tracking systems
- Able to coordinate document review and finalization across multiple stakeholders
- Quick to learn new software programs and databases
- Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate
What We Offer:
Medical, dental, and vision insurance
FSA, HSA
Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
Group short-term and long-term disability insurance
Group Life Insurance
401K safe harbor plan and company match
Paid vacation, holiday, sick and volunteer time
Paid maternity & paternity leave
What Sets Us Apart:
WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.
How We Work at WEP Clinical:
At WEP Clinical, we look for individuals who are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
Data Privacy Notice:
WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice. Privacy Policy: https://www.wepclinical.com/privacy-policy/
Job Applicant Privacy Notice: https://www.wepclinical.com/privacy-policy/
How to Apply:
To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.
Important Note:
To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.
For Your Safety, Please Note:
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any stage of recruitment
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.
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