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
* 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 / week
Location: Remote