TMF Lead I

The role

The TMF Lead supports project teams in maintaining a high quality TMF in accordance with GCP, guidance documents, and Precision SOPs. This role involves managing TMF document review, processing, setup, maintenance, and archival.

What you will do

• Ensure TMF document review, processing, setup, maintenance, finalization and archival is completed timely and with high quality.
• Create and execute the study TMF Plan and project TMF Document Index.
• Ensure TMF documentation is filed in the TMF.
• Attend and contribute to project meetings to ensure the team is aware of TMF status, gaps and escalations.
• Collaborate with Project Managers and Functional Leads to maintain an inspection-ready TMF.
• Identify and mitigate TMF compliance risks and implement plans to increase compliance.
• Monitor and report on TMF Health and Metrics.
• Serve as Subject Matter Expert for project audits or inspections.
• Provide TMF analytics and expertise to Sponsors.
• Manage study close-out activities including final document submission and eTMF export.

Required qualifications

• 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 & ICH/GCP regulations and guidelines.
• Solid interpersonal skills.
• Ability to identify issues and escalate appropriately and effectively.
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
• Ability to manage competing priorities effectively.
• Ability to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance.
• Self-motivation, detail-oriented, and able to work and plan independently as well as in a team environment.
• Professionalism, punctuality, and ability to deliver on commitments.
• Efficient and professional verbal and written communication.

About the company

Precision Medicine Group is an Equal Opportunity Employer.