Clinical Trial Manager - Oncology, Sponsor Dedicated (Hybrid)

About the role

Syneos Health is hiring a Clinical Trial Manager to work sponsor dedicated on oncology studies. The position is based at the client's office in Rueil-Malmaison with 50% home working. The manager oversees study delivery at country level, from start-up to closure, and acts as the main point of contact for internal and external stakeholders.

Key responsibilities

• Coordinate country cross-functional teams and liaise with the protocol manager and global study team
• Coordinate site feasibility, including proposal and validation of country study targets
• Develop the country-level patient recruitment strategy and ensure enrolment targets and timelines are met
• Lead problem solving, risk management, contingency handling and escalation
• Assess and set up vendors during study start-up, and prepare materials for site initiation visits
• Ensure clinical trial management system data is current and complete, and that eDC and vendor system access is available
• Validate study materials such as protocol, informed consent forms and patient materials
• Prepare country-specific documents, verify eTMF completeness, and review site monitoring reports
• Coordinate database locks and query follow-up, and ensure inspection readiness
• Support Health Authority and ethics committee submissions, and lead CAPA for audit findings
• Review and approve payments, manage patient compensation claims, and manage site relationships including CRO issues
• May handle site closure, act as site point of contact, and lead local study team meetings

Required profile

• Thorough understanding of GCP, ICH guidelines and the country regulatory environment
• In-depth knowledge of clinical research processes, regulations and methodology
• Practical knowledge of medical settings and medical records management
• Experience leading or taking part in cross-functional teams, task forces or local and global initiatives
• Strong organisation, planning, time management and critical thinking skills
• Strong communication skills with a customer focus, able to manage internal and external clients

Required skills

• GCP and ICH guidelines
• Clinical trial management systems (e.g. eDC)
• eTMF

What we offer

• Competitive remuneration package with excellent benefits
• Development and training opportunities, with career progression