Quality control (QC) review of submitted study documents in the eTMF for completeness, timeliness and quality – including correct filing, versioning, metadata and compliance with the ALCOA+ criteria
Approval or justified rejection of documents, traceable documentation of your review decision and consistent follow-up of corrections
Development and maintenance of the study-specific TMF structure based on the TMF Reference Model, including placeholders, milestones and adjustments during the course of the study.
Monitoring of completeness and deadline indicators, preparation of regular TMF status reports and active follow-up of missing or overdue documents from study teams and trial centers.
Ensuring inspection readiness throughout the entire study period, as well as providing support during audits and regulatory inspections.
Participation in the TMF plan, filing conventions and associated SOPs, as well as training of study teams and trial centers on our filing and quality requirements.
Your profile
Completed training in the medical or scientific field, a relevant degree or comparable qualification
Experience in clinical research, especially in TMF management, or alternatively experience in clinical operation (sponsor, CRO) or study coordination (trial site)
Good knowledge of ICH-GCP guidelines and relevant regulatory requirements, and experience with SOP-based work (Naming Convention, TMF Plan, TMF Index).
Confident use of MS Office and electronic document management systems
Structured, meticulous and independent work style
Analytical thinking and an interest in process optimization, as well as the ability to react flexibly to changing requirements.
Excellent German and English skills, both spoken and written.
Persistence and commitment in following up on open issues, even if multiple follow-ups are necessary.
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