Provide oversight of Trial Master File management across clinical development programs and functions.
Partner closely with Clinical Operations, Clinical Supply Chain, Data Management, Pharmacovigilance, Regulatory Affairs, and other development functions to ensure essential clinical documentation is appropriately maintained within the TMF.
Facilitate periodic TMF health discussions and ensure alignment on TMF quality and completeness expectations.
Interface with CROs and external vendors responsible for TMF activities and contributes to maintaining TMF inspection readiness across the organization.
Support TMF lifecycle activities including study start-up planning, ongoing TMF maintenance, study closeout, and TMF archival in accordance with regulatory and company retention requirements.
Establish and maintain consistent TMF management practices across studies and programs.
Conduct routine TMF health reviews and collaborate with study teams and document content owners to identify documentation gaps and ensure appropriate remediation.
Oversee quality, completeness, and timeliness of Trial Master File (TMF/eTMF) documentation across clinical studies.
Develop and track eTMF metrics for studies and communicate trends or issues identified to study teams and management.
Serve as the eTMF system administrator, supporting user access management, system configuration support, troubleshooting, and ongoing optimization of system functionality.
Support regulatory inspections and internal audits involving TMF records and management.
Collaborate with the Head of Clinical Quality Assurance and system users to identify opportunities to improve TMF processes, system functionality, and inspection readiness practices.
Work with the eTMF system owner and IT or system support teams to implement system improvements in accordance with required change control and validation procedures.

Requirements

Bachelor’s degree plus 8 Years experience in life sciences, pharmacy, or related scientific discipline or commensurate work experience managing TMFs.
Pharmaceutical, biotechnology, or CRO experience with direct involvement in Trial Master File management desired.
Strong knowledge of regulatory requirements and industry expectations related to clinical trial documentation and Trial Master File management.
Trial Master File (TMF) oversight and electronic TMF systems.
Clinical trial documentation requirements and the TMF Reference Model.
TMF health review and document completeness monitoring.
Regulatory inspection readiness and inspection support.
Cross-functional collaboration with clinical development functions.
Working knowledge of global Good Clinical Practice (GCP) requirements and regulatory expectations for clinical trial documentation.
Experience contributing to:
TMF process improvement initiatives
eTMF system administration or system governance
TMF metrics development and monitoring
TMF closeout and archival processes
Experience working with CROs or vendors responsible for TMF activities.

Benefits

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Trial Master File managementeTMF systemsTMF health reviewdocument completeness monitoringTMF metrics developmentTMF closeout processesTMF archival processessystem administrationprocess improvement initiativesregulatory requirements

Soft Skills

cross-functional collaborationcommunicationoversighttroubleshootingorganizational skillsleadershipproblem-solvingattention to detailquality assurancestakeholder engagement