TMF Associate

Salary $50/hr - $60/hr
LocationSouth San Francisco, California
Employment type Contract
Discipline
Life Sciences

Job description

rial Master File (TMF) Associate

POSITION SUMMARY
The TMF Associate will support the organization’s Trial Master File (TMF) Operations by contributing to day-to-day TMF project activities, TMF key performance indicators (KPIs), electronic Trial Master File (eTMF) system management, vendor TMF oversight, and functional subject matter expertise. The role requires strong adherence to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good Documentation Practices (GDP), International Council for Harmonisation E6(R2) guidance, and ALCOA+ principles.

The candidate will collaborate with external vendors and cross-functional internal teams, playing a key role in TMF lifecycle management and ensuring compliance with applicable global regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Support Clinical Operations teams in day-to-day eTMF system activities

  • Contribute to development and maintenance of the TMF Plan and TMF Index for each study, including updates as needed

  • Ensure compliance with organizational and/or vendor TMF SOPs, KPI frameworks, and global regulatory guidance

  • Perform document-level quality reviews and coordinate with document owners to resolve quality findings in accordance with TMF procedures

  • Support definition and maintenance of expected document lists and placeholders within the eTMF system in partnership with Clinical Operations and CRO partners

  • Conduct risk-based quality control and TMF health assessments to support sponsor oversight and inspection readiness

  • Track and report TMF performance metrics at core, country, and site levels, identifying trends in completeness, quality, and timeliness and escalating issues when appropriate

  • Monitor outsourced TMF activities and vendor performance, escalating concerns as necessary

  • Support remediation of documents that fail quality or inspection readiness reviews by coordinating with internal or external stakeholders and recommending best practices

  • Assist with long-term archival and retention of essential documents while maintaining document integrity in accordance with record retention requirements

  • Demonstrate organizational core values such as patient focus, integrity, innovation, and commitment to quality

REQUIREMENTS

Education

  • Bachelor’s degree or equivalent required

Experience

  • Minimum of 3+ years of clinical research experience, including document management, vendor oversight, quality control review, and completeness assessments

  • Working knowledge of drug development processes, ICH guidelines, GCP, clinical trial operations, SOP application, and medical terminology

  • Self-motivated with the ability to collaborate and influence others

  • Strong interpersonal, analytical, planning, and organizational skills

  • Excellent verbal and written communication skills with high attention to detail

  • Ability to prioritize tasks and meet critical deadlines

  • Proficiency in Microsoft Office applications including Word and Excel