TMF Lead I: Compliance & Study Integrity

Precision Medicine Group (New York, United States); United States; Remote; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

Precision Medicine Group in New York seeks a Senior TMF Lead to support project teams in maintaining a high-quality TMF in line with GCP, FDA/ICH guidelines, and Precision SOPs. The role mentors junior TMF Leads and ensures inspection readiness across studies.

The Senior TMF Lead collaborates with project teams to manage TMF plans, indexes, and documentation, driving timely compliance and governance. Strong communication and risk management are essential.

Qualifikationen

• Bachelor’s degree (or international equivalent) with 5+ years of related TMF experience.
• Experience maintaining TMF in compliance with GCP, FDA/ICH and SOPs.
• Ability to mentor junior TMF Leads and communicate with stakeholders.

Aufgaben

• Maintain high-quality TMF by overseeing review, quality checks, and archival.
• Develop and execute study TMF Plan and TMF Index; communicate changes.
• Ensure TMF documents are filed and accessible in the TMF system.
• Attend meetings and communicate TMF status to project teams.
• Collaborate with Project Manager and Leads to ensure timely TMF submission.
• Identify TMF risks, implement mitigation plans, and escalate as needed.
• Monitor TMF health and metrics; report trends to leadership.
• Serve as SME for audits/inspections and support responses.
• Provide TMF analytics and subject-matter expertise to Sponsors.

Kenntnisse

FDA & ICH/GCP knowledge

Interpersonal skills

Issue identification & escalation

Organizational skills

Prioritization

Mentoring/Training

Detail-oriented

Team collaboration

Effective communication

Ausbildung

Bachelor’s degree +5 years experience

Tools

eTMF System

Jobbeschreibung

Precision Medicine Group in New York seeks a Senior TMF Lead to support project teams in maintaining a high-quality TMF in line with GCP, FDA/ICH guidelines, and Precision SOPs. The role mentors junior TMF Leads and ensures inspection readiness across studies.

The Senior TMF Lead collaborates with project teams to manage TMF plans, indexes, and documentation, driving timely compliance and governance. Strong communication and risk management are essential.