Clinical Trials Document Specialist
2 weeks ago
We are seeking a highly organized and detail-oriented TMF Manager to oversee and manage the Trial Master File (TMF) for assigned clinical trials.
This is an excellent opportunity for someone with strong clinical documentation expertise, exceptional organizational skills, and the ability to collaborate effectively across cross-functional teams.
Key Responsibilities:- Set up, oversee, and lock clinical TMFs for assigned studies.
- Ensure the quality of Clinical Department Trial Master Files at all times.
- Lead TMF kick-off meetings with clinical teams and CROs.
- Maintain and update TMF Plans throughout the study lifecycle.
- Monitor TMF quality and completeness, providing metrics and reports as needed.
- Provide guidance and oversight to Associate TMF Managers and Clinical Documentation Administrators.
- Act as the main point of contact for TMF contributors, providing expertise on TMF processes and eTMF systems.
- Coordinate TMF readiness for audits and inspections.
- Lead TMF reviews and secure final archiving of TMFs.
Requirements:
- Clinical documentation expertise and experience in managing trial master files.
- Excellent organizational and communication skills.
- Able to work effectively in a team environment.
Benefits:
- Opportunity to work in a dynamic and growing organization.
- Collaborative team environment.
- Professional development opportunities.
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