PharmaLex · 15 hours ago
TMF Study Owner
Trenton, NJ
Full-time
Onsite
Senior Level
5+ years expPharmaLex is an innovative company focused on creating healthier futures, and they are seeking a TMF Study Owner to provide pivotal support and subject matter expertise at a study level. The role involves ensuring Trial Master Files are inspection ready and maintaining TMF health, consistency, and compliance across clinical trials.
BiotechnologyConsultingHealth CareMedicalPharmaceutical
Responsibilities
Remain Familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance, e.g., Good Documentation Practices
Support the set-up of the study-specific TMF structure, liaising with the Study Team to establish requirements
Monitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implemented
Monitor milestones and events to ensure TMF Completeness via eTMF functionality
Write/initiate creation of the study-specific TMF Management Plan in collaboration with Study Team
Support study team through closeout and archive preparations
Ensure ongoing adherence to TMF SOPs and specifications
Create study-specific TMF Index (or equivalent). TMF Metrics
Perform and/or support Quality Review and perform spot-checks for quality oversight
Provide TMF Health status updates and review metric reports outputs on a recurring basis, with guidance on improving and maintaining
Help facilitate, track, and support periodic Study Team TMF Reviews
Perform a deep dive of report outputs; identify and share trends and risk areas with Study Teams
Manage remediation and reconciliation projects
Manage inspection preparation
Support audits and inspections
Support implementation of CAPAs at study level
Identify and escalate risk and trends impacting Inspection Readiness
Facilitate TMF-focussed communication and collaboration between Sponsor and CROs
Communicate to the Study Manager (or equivalent) on all aspects of the TMF
Build proactive relationships with study teams, providing continued SME support
Understand and utilise appropriate escalation pathways
Provide feedback on processes relating to TMF Management
Act as TMF SME, including related processes, to provide ongoing support to the Study Team
Provide feedback to support the development of internal and/or external TMF-related trainings
Conduct training for Study Team and/or colleagues, either 121 or in group setting
The employee agrees to take over additional reasonable tasks that align with their abilities, if required
Qualification
Required
Degree level education preferred, but equivalent work experience in a relevant field considered
5 years' relevant industry experience in Clinical or TMF Operations oversight
Excellent knowledge of Good Documentation Practices (GDP) and document recognition
Good knowledge of referencing/applying applicable resources
Working Knowledge Of Clinical trial lifecycle
Working Knowledge Of TMF Reference Model (or equivalent)
Working Knowledge Of eTMF systems
Working Knowledge Of TMF Health & Metrics, including Quality Review process
Working Knowledge Of Internal communication/escalation pathways
Familiar With TMF lifecycle
Familiar With Other clinical/document management systems
Familiar With TMF stakeholders
Familiar With End-to-end tasks, including TMF set-up process and Management Plans
Familiar With TMF training
Familiar With Inspection Readiness
Familiar With External communication/escalation pathway
Proficient in verbal and written communication
Benefits
Medical, dental, and vision care
Backup dependent care
Adoption assistance
Infertility coverage
Family building support
Behavioral health solutions
Paid parental leave
Paid caregiver leave
Training programs
Professional development resources
Opportunities to participate in mentorship programs
Employee resource groups
Volunteer activities
Company
PharmaLex
PharmaLex provides specialized services for the pharma, biotech, and medtech industries.
1001-5000 employees
H1B Sponsorship
PharmaLex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (7)
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2022-09-12Acquired
Recent News
2025-10-31
2025-08-19
Company data provided by crunchbase