RWE Study Lead – France & Germany

Resilience Care; Nantes; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Resilience Care in France is seeking a Senior Project Lead for Real-World Evidence studies in Germany and/or France. You will own execution from protocol to final report, coordinating clinical research, remote monitoring and health data.

You will manage timelines and budgets, activate sites with local teams, and oversee CRO partners. Collaboration with Medical, Clinical Operations and Data teams will shape reusable methods. English required.

Qualifications

• Lead a clinical or non-interventional study end to end.
• Navigate the German or French research environment: ethics committees, GDPR, Länder-level data protection requirements and hospital contracting.
• Oversee a CRO and its deliverables, with sponsor responsibilities, pharmacovigilance and monitoring plans.
• Track a study budget and make variances, risks and necessary trade-offs visible.
• Assess clinical data quality and discuss EHR structuring and AI-assisted extraction.
• Work fluently and use professional English in writing and speaking.

Responsabilités

• Lead studies from contracting to the final report, including protocol and statistical analysis plan coordination, ethics submissions, data collection and deliverables.
• Maintain an actionable project timeline, anticipate risks and propose solutions before milestones are affected.
• Track study budgets, committed expenditure, site costs and CRO costs.
• Select and activate sites with local teams, coordinate site contracting and oversee CRO partners.
• Act as the sponsor’s primary operational contact and lead steering committees with international pharmaceutical partners.
• Work with Medical, Clinical Operations, Data, Legal and Quality teams, and turn delivery experience into reusable methods.

Connaissances

RWE studies

Project management

Budget tracking

CRO coordination

Ethics submissions

GDPR knowledge

English proficiency

Description du poste

Resilience Care in France is seeking a Senior Project Lead for Real-World Evidence studies in Germany and/or France. You will own execution from protocol to final report, coordinating clinical research, remote monitoring and health data.

You will manage timelines and budgets, activate sites with local teams, and oversee CRO partners. Collaboration with Medical, Clinical Operations and Data teams will shape reusable methods. English required.