TMF Excellence Lead - Trial Master File Oversight

SK Life Science, Inc.; Paramus (NJ); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

401(k) match

Medical, dental, and vision coverage

Job summary

SK Life Science, Inc. seeks a TMF Specialist to join Clinical Operations in Paramus, NJ. You will own the TMF lifecycle end-to-end, ensuring inspection readiness and compliant documentation across trials.

This role emphasizes proactive issue identification, remediation actions, and sponsor oversight to maintain study integrity. Responsibilities include establishing TMF plans, overseeing CRO/vendor activities, performing gap analyses, and maintaining trackers.

Qualifications

• Bachelor's degree in life sciences, healthcare, or related discipline.
• 3-5+ years of Clinical Operations/TMF experience.
• Strong knowledge of TMF principles and ICH GCP.
• Experience with electronic TMF systems and CRO-managed TMFs.

Responsibilities

• Serve as the primary TMF subject matter expert and central point of contact for TMF activities across all assigned clinical studies.
• Provide end-to-end ownership and sponsor oversight of the TMF lifecycle from study start-up to archival.
• Establish and review study-specific TMF plans, filing structures, and escalation pathways at study initiation.
• Oversee CRO and vendor TMF activities for compliance with plans, SOPs, and regulations.
• Conduct routine reviews to assess TMF completeness, quality, and timeliness; identify gaps and remediation actions.
• Maintain TMF action-item trackers, issue logs, and dashboards; ensure closure of findings.
• Coordinate final TMF quality review, reconciliation, transfer, and archival activities.
• Support audits and inspections by maintaining inspection readiness and timely documentation retrieval.
• Collaborate with Clinical Operations, QA, Regulatory, Data Management, and other functions to meet TMF requirements.
• Contribute to TMF SOPs, templates, and training.

Skills

Organizational skills

Follow-up skills

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in life sciences/healthcare

3-5+ years Clinical Operations/TMF experience

Tools

Electronic TMF systems

Job description

SK Life Science, Inc. seeks a TMF Specialist to join Clinical Operations in Paramus, NJ. You will own the TMF lifecycle end-to-end, ensuring inspection readiness and compliant documentation across trials.

This role emphasizes proactive issue identification, remediation actions, and sponsor oversight to maintain study integrity. Responsibilities include establishing TMF plans, overseeing CRO/vendor activities, performing gap analyses, and maintaining trackers.