TMF Lead I
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Job Description
TMF Lead maintaining compliant, inspection-ready trial master files for Precision for Medicine’s clinical research services. Managing TMF plans, risks, audits, metrics, and study closeout.
Responsibilities:
- Support project teams in maintaining high-quality Trial Master Files (TMFs) in accordance with GCP, guidance documents, and Precision SOPs
- Ensure timely, high-quality TMF document review, processing, quality review, setup, maintenance, finalization, and archival
- Create and execute study TMF Plans and project TMF Document Indexes
- Communicate TMF expectations, project-specific requirements, and changes to study teams
- Attend and contribute to project kick-off, internal, external, and ad hoc meetings
- Collaborate with Project Managers and Functional Leads to maintain inspection-ready TMFs
- Identify TMF compliance risks, develop mitigation plans, and follow escalation processes
- Monitor and report TMF health, metrics, trends, risks, and non-compliances
- Serve as point of contact and subject matter expert for project audits and inspections
- Provide TMF analytics and expertise to sponsors
- Oversee periodic quality reviews and document processing by assigned specialists
- Identify TMF training needs and provide or support team re-education
- Manage study close-out activities, including final submissions, query closure, eTMF export, sponsor transfer, and receipt acknowledgment
- Manage projects within sponsor eTMF systems
- Monitor and report potential out-of-scope Records Management activities
- Support and mentor less experienced TMF Leads
Requirements:
- Bachelor’s degree (or its international equivalent) + 5 years of related experience, or equivalent combination of education, professional training and experience
- Working knowledge of FDA and ICH/GCP regulations and guidelines
- Working knowledge of relevant Precision SOPs and regulatory guidance
- Ability to identify issues and escalate appropriately and effectively
- Excellent organizational skills and time management
- Ability to coordinate workload and meet established deadlines
- Ability to manage competing priorities effectively
- Strong self-motivation and attention to detail
- Ability to work and plan independently and in a team environment
- Professional verbal and written communication skills
- Must be legally authorized to work in the country of employment without employer sponsorship
Benefits:
- Equal Opportunity Employer
- Reasonable accommodation available for applicants with disabilities
- AI opt-out request available during the application journey
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