SciPro

Trial Master File Specialist Job at SciPro in San Francisco

SciPro, San Francisco, CA, United States

Trial Master File (TMF) Specialist

6-month initial contract (potential for extension & possible conversion to FTE)

San Francisco Bay Area, CA (hybrid)

Responsibilities

Act as the primary GPS TMF lead, coordinating cross-functional TMF management for clinical studies
Follow Standard Operating Procedures (SOP), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and ALCOA+ standards
Update cross-functional teams on TMF filing progress to support study objectives
As the GPS subject matter expert, draft, review, and oversee all eTMF Plans, Index, SOPs, and related documents
Perform quality checks on uploaded documents to ensure accuracy and correct indexing
Oversee the quality of study TMFs, managing TMF metrics and key performance indicators (KPIs)
Collaborate with CROs/vendors and team members to coordinate TMF activities
Manage systems for cataloging, filing, retrieving, saving, and transferring TMF records for both internal and vendor processes
Build and maintain effective working relationships with CROs/vendors for TMF management
Support GPS TMF-related audit and inspection activities
Contribute to eTMF uploads for applicable clinical studies, as needed
Engage in other GPS functions as appropriate

Required Skills, Experience, and Education

Bachelor’s degree, ideally in biological sciences or a health-related field
At least 2 years of TMF management experience within Pharmacovigilance/Safety
Strong understanding of international safety regulations and compliance in safety reporting
Proficient in the DIA TMF Reference Model or equivalent, ICH-GCP, ALCOA+ standards, and document management regulations
Demonstrated ability to manage TMFs effectively, including developing related processes and policies
Ability to work well in collaborative, fast-paced team settings, adapting as needed
Excellent communication, interpersonal, and decision-making skills
Strong commitment to prioritizing tasks and achieving deliverables with high standards
Proficient in SharePoint and various eTMF platforms (e.g., Veeva, Trial Interactive, WingSpan, FLEX)
Skilled in Microsoft Office (Outlook, Word, Excel, PowerPoint); knowledge of MS Project or Smartsheet is a plus
Willingness to travel up to 25%, if working remotely

Pay rate: $35 - $40/hr. W2

Preferred Skills, Experience and Education