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TMF Manager (M/F/D)
Tasks:
- Manage, review, and quality-check (paper)TMF documents, including uploads, indexing, and compliance with TMF plans
- Ensure inspection readiness through timely and complete documentation aligned with study milestones
- Serve as TMF Subject Matter Expert and main contact for study teams and stakeholders
- Coordinate with internal departments and external partners (CROs, vendors) to resolve TMF gaps
- Oversee TMF close-out, archiving, and develop reports, metrics, and training tools
Qualification:
- Strong (paper)TMF experience, including document quality review and compliance
- Clinical trial experience, ideally in hemato-onco and/or advanced medical therapies; knowledge of international trials
- Proficient in TMF software and nice-to-have familiar with DIA Reference Model
- Detail-oriented, structured, team-oriented, and flexible; strong communication and collaboration skills
- Excellent command of English, both written and verbal; proficiency in German is an advantage
Requirements:
Start: asap
Duration: 6 months (option for extension)
Capacity: 5 days per week
Location: Hybrid (3:2 – Cologne area : remote)
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