TMF Lead I: QA & Compliance for Clinical Studies

Jobicy; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Precision Medicine Group is seeking a Senior TMF Lead to support project teams in maintaining inspection-ready TMFs in line with GCP and SOPs. You will mentor junior TMF staff and lead complex studies with a focus on risk identification and issue resolution.

You will collaborate with Project Managers and Functional Leads to ensure timely TMF plans, indices, and quality reviews, while driving continuous improvements in TMF health and compliance.

Qualifications

• Bachelor’s degree and 5+ years of related experience or equivalent combination.
• Working knowledge of FDA & ICH/GCP regulations and guidelines.
• Demonstrates strong interpersonal, organizational, and communication skills.
• Ability to identify issues and escalate appropriately and effectively.
• Ability to manage multiple priorities and meet deadlines.

Responsibilities

• Ensure TMF document review, periodic quality review, setup, maintenance, finalization and archival of study TMFs is completed on time and with high quality.
• Create and execute the study TMF Plan and Project TMF Document Index; ensure team understanding and communicate changes.
• Maintain TMF documents (Plan, Index, PQR) in the TMF system.
• Participate in kick-off, internal/external meetings to communicate TMF status, gaps, and escalations.
• Collaborate with Project Manager and Leads to ensure timely, quality TMF submissions and inspection readiness.
• Identify risks to TMF compliance and implement mitigation plans; escalate as needed.
• Identify TMF risks and document/mitigate them; monitor TMF health and metrics.
• Serve as SME for audits/inspections and support responses; participate in interviews.
• Provide TMF analytics and expertise to Sponsors; support periodic quality reviews.
• Oversee document review by Document Specialists; mentor less experienced TMF Leads.
• Plan and manage close-out activities for assigned studies; coordinate eTMF export, transfer, and receipt acknowledgement.
• Manage Sponsor eTMF System projects and communicate insights to stakeholders.
• Identify out-of-scope Records Management activities and ensure proper change orders.
• Support and mentor junior TMF staff in problem solving.

Skills

FDA & ICH/GCP

Interpersonal skills

Issue identification

Time management

Prioritization

ICH-GCP knowledge

Self-motivation

Detail-oriented

Professionalism

Effective communication

Company values

Education

Bachelor’s degree +5 years

Job description

Precision Medicine Group is seeking a Senior TMF Lead to support project teams in maintaining inspection-ready TMFs in line with GCP and SOPs. You will mentor junior TMF staff and lead complex studies with a focus on risk identification and issue resolution.

You will collaborate with Project Managers and Functional Leads to ensure timely TMF plans, indices, and quality reviews, while driving continuous improvements in TMF health and compliance.