Documentation Specialist

WEP Clinical partners with biopharmaceutical sponsors to support clinical trial delivery, patient access, and drug development. The Documentation Specialist supports the setup, maintenance, quality review, reporting, auditing, and archival of Trial Master File documentation in accordance with SOPs, GCP, ICH guidelines, and project-specific plans.

Responsibilities

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

Preferred

- Bachelor's degree preferred

- 1 - 2 years of experience in order processing and documentation management systems preferred

- Experience with clinical trial electronic databases preferred

Bachelor’s Degree

Order Processing

Documentation Management Systems

Clinical Trial Electronic Databases

Benefits

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

Many initiatives to encourage wellness, growth and development, and team relationships

Remote work arrangement

Company

Specialist CRO for clinical trials, expanded access programs.

London, England, GBR

http://www.wepclinical.com/

Founded in 2008

501-1000 employees

Qualifications

- Detail-oriented

- Highly Organized

- Adaptable

- Team Player

- Familiarity with clinical study documentation, including QC, SOPs, GCP guidelines, and archiving best practices

- 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

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

- Bachelor's degree preferred

- 1 - 2 years of experience in order processing and documentation management systems preferred

- Experience with clinical trial electronic databases preferred

Required skills

Clinical Trial Documentation, Electronic Trial Master File (eTMF) Management, Clinical Study Documentation Quality Control, Standard Operating Procedures (SOPs), Clinical Practice (GCP), International Council for Harmonisation (ICH) Guidelines, Clinical Trial Electronic Databases, Microsoft Office, Document Formatting and Publishing, Document Tracking Systems

Preferred skills

- Bachelor's degree preferred

Experience

1-2 years