Study Manager

K-Recruiting Life Sciences; Leipzig; Remote; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A life sciences recruiting firm is seeking an RWE Study Manager to confirm study statuses and coordinate with global teams. The candidate should be experienced in RWE/NIS and knowledgeable about EMA/BfArM guidelines. This remote position requires fluency in English and German, with an immediate start for a duration of 6 months, working 1 day a week.

Qualifikationen

• Experience with RWE / NIS and post-approval submissions.
• Strong knowledge of EMA / BfArM guidelines.
• Fluent in both English and German.

Aufgaben

• Confirm retrospective non-interventional status.
• Conduct GDPR + ethics check.
• Determine BfArM notification needs.
• Prepare minimal protocol + study docs.
• Coordinate with global RWE / clinical team.
• Review final data.
• Submit notification if required.
• Update post-marketing files if relevant.

Kenntnisse

Experience with RWE / NIS

Knowledge of EMA / BfArM guidelines

Fluent in English

Fluent in German

Jobbeschreibung

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

Qualifications

• 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