TMF and Clinical Documentation Associate Director. Remote position with the HQ in Berlin.
A global pharmaceutical company with a growing clinical pipeline is hiring a senior professional to take leadership over its documentation and TMF strategy across multiple global studies.
This person will be responsible for overseeing the full document management lifecycle of clinical trial documentation — from the implementation of standards and systems to oversight of inspection-readiness activities. You’ll work closely with internal teams and external vendors to ensure that all clinical records are maintained to the highest compliance and quality standards.
Ensure alignment with global regulations (ICH-GCP) and internal quality systems
Support cross-functional collaboration with Clinical Operations, QA, and Regulatory Affairs
Background in clinical research or document management within the pharmaceutical, biotech, CRO or other life science field.
Hands-on knowledge of electronic Trial Master Forms (eTMF) tools and document lifecycle management
Leadership - ideally you have previous line management experience but open to those who have only mentored / relevant coaching etc experience.
Experience managing documentation processes across international studies which can cover any area (Regulatory, Audit, Clinical Trial Documentation, Trial Readiness).
Strong communication and project coordination skills
relocation support available for the right candidate - visa support not provided at this time.
Language: English (German a plus but not essential).
Work alongside global teams driving clinical development
If you’ve built or improved TMF and document control systems and want to take the lead in shaping best practices across trials, we want to like to hear from you.