Documentation Specialist

Lever, Inc.; United States; Remote; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

FSA, HSA

Voluntary Insurance: Critical Illness,

Group disability insurance

Group Life Insurance

401K company match

Paid vacation and holidays

Paid maternity & paternity leave

Job summary

WEP Clinical is seeking a Documentation Specialist to support TMF management in alignment with SOPs, GCP, and ICH guidelines. You will coordinate eTMF setup, QC reviews, and archival activities while collaborating with cross-functional project teams.

The role requires attention to detail, strong organizational skills, and proficiency in Microsoft Office. US-based location is expected, with a focus on timely document delivery and regulatory compliance.

Qualifications

• Bachelor’s degree preferred.
• Experience with TMF, SOPs, GCP, and ICH guidelines.
• Experience with clinical trial electronic databases.
• Proven ability to meet quality and timeline objectives.
• Strong computer skills and document management systems.

Responsibilities

• Support electronic Trial Master File (eTMF) setup, maintenance, and closeout in accordance with SOPs, 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.

Skills

Detail-oriented

Highly Organized

Adaptable

Team Player

Education

Bachelor’s degree preferred

Tools

Microsoft Office

Job description

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 Specialistis 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.

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 outour 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 individualswho 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/

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.