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 Educatio

n:Bachelor’s degree, ideally in biological sciences or a health-related fiel
d.At least 2 years of TMF management experience within Pharmacovigilance/Safet
y.Strong understanding of international safety regulations and compliance in safety reportin
g.Proficient in the DIA TMF Reference Model or equivalent, ICH-GCP, ALCOA+ standards, and document management regulation
s.Demonstrated ability to manage TMFs effectively, including developing related processes and policie
s.Ability to work well in collaborative, fast-paced team settings, adapting as neede
d.Excellent communication, interpersonal, and decision-making skill
s.Strong commitment to prioritizing tasks and achieving deliverables with high standard
s.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 plu
s.Willingness to travel up to 25%, if working remotel

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

W2
Preferred Skills, Experience and Educat

tage

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