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RWE Study Manager (M/F/D)
Tasks:
- Confirm retrospective non-interventional status
- GDPR + ethics check
- Determine if BfArM notification is needed
- Prepare minimal protocol + study docs
- Coordinate with global RWE/clinical team
- Review final data
- Submit simple notification if required (no eCTD)
- Update post-marketing files (PSUR/RMP) if relevant
Qualification:
Experience with RWE / NIS and post-approval submissions
Strong knowledge of EMA / BfArM guidelines
Fluent in English and German
Requirements:
Start: asap
Duration: 6 months
Capacity: 1 day per week
Location: Remote
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