RWE Delivery Manager – French/Germany

This is a fully remote position, open to applicants in France, +1 more country.

📋 Description

• Oversee Real-World Evidence studies from the contracting phase to the final report.

• Manage protocols, statistical analysis plans, ethics submissions, data collection, and deliverables.

• Ensure project timelines are met, anticipate potential risks, and suggest mitigation strategies.

• Monitor study budgets, committed expenditures, site costs, and costs associated with CROs.

• Identify and activate study sites in collaboration with local teams.

• Coordinate site contracting and supervise CRO partners.

• Act as the primary operational contact for the sponsor.

• Lead steering committees with international pharmaceutical collaborators.

• Work in collaboration with Medical, Clinical Operations, Data, Legal, and Quality teams.

• Create reusable methodologies based on delivery experiences.

⛳️ Requirements

• Proven experience in leading clinical or non-interventional studies from start to finish.

• Familiarity with the German research landscape, including ethics committees, GDPR/DSGVO, Länder-level data protection regulations, and hospital contracting.

• Experience in overseeing a CRO and managing its deliverables from the sponsor's perspective.

• Comprehensive understanding of sponsor responsibilities, pharmacovigilance, and monitoring plans.

• Proficient in tracking study budgets, committed expenditures, site costs, and CRO costs.

• Capability to evaluate clinical data quality and engage in discussions regarding electronic health record structuring and AI-assisted extraction.

• Proficiency in German.

• Strong professional English skills, both written and spoken.

• Experience collaborating with investigator sites and research partners within the German ecosystem.

• Background in coordinating cross-functional teams and presenting project updates to sponsors or pharmaceutical partners.

• Experience in oncology or hematology is advantageous.

🏝️ Benefits

• Participate in research that is rooted in real care pathways, collaborating with sites and medical teams.

• Lead studies that integrate remote monitoring, patient-reported outcomes, and clinical data.

• Enjoy comprehensive project ownership with accountability for execution and outcomes.

• Opportunity to establish lasting methodologies and partnerships with an international, multidisciplinary team.