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Trial Master File (TMF) Specialist

Brisbane, CA 94005

Posted: 11/20/2025 Employment Type: Contract Industry: Administration Job Number: 12444 Pay Rate: $44.00-$54.00 Remote Friendly: remote

Job Description

Our client is focused on advancing first- or best-in-class medicines for childhood and adult diseases.

Responsibilities:
  • Assists with TMF Remediation Project
  • Ensures the TMF project documentation is maintained to the highest level of quality, accuracy, completeness, and compliance with regulations and business procedures
  • Manages and oversees document review processes and systems for GCP activities in compliance with regulatory requirements and business procedures
  • Implements/maintains TMF quality control processes aligned to company standards and within regulatory requirements
  • Organizes and provides TMF process implementation training to study teams ensuring compliance with SOPs, WIs and regulatory requirements
  • Coordinates TMF documentation collection, review, and submission with stakeholders
  • Manages and tracks TMF-related actions, decisions, issues, and risks
  • Conducts periodic study-specific TMF reviews ensuring GxP inspection readiness in accordance with regulations and business procedures
  • Supports company management with successful eTMF system’s global implementation
  • Supports the coordination of the transfer of study-specific TMF content from applicable vendors
  • Assesses project or assignment details
  • Communicates updates and issues that arise with supervisors, managers, or other team members
  • Effectively manages priorities and project timelines to meet deadlines

Job Requirements

Requirements:
  • Veeva Vault Certification (Preferred)
  • BS Degree required
  • 3+ years relevant experience within the pharmaceutical or biopharmaceutical industry
  • Knowledge of international and local regulatory requirements for clinical trials and guidelines, such as ICH-GCP and FDA & EMA regulations
  • Experience with GxP systems, preferably Veeva Vault and with other technologies such as MS Office
  • Ability to manage, organize, and maintain large amounts of documentation, both electronic and paper
  • Effective communication and interpersonal skills
  • High attention to detail to ensure that all TMF documentation meets ALCOA+ standards
  • Ability to identify and manage risks and resolve issues in a timely manner
  • Skilled at problem-solving and proposing solutions
  • Able to work with minimal supervision
  • Strong time-management, communication, and organizational skills

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About Brisbane, CA

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