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