Clinical Research

• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes.
• Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
• Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
• Build and manage strong relationships with trial investigators and stakeholders.
• Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.

Clinical Trial Manager

• Accountable for regional study delivery with appropriate inspection-ready quality, within agreed timelines and budget.
• Lead the regional clinical operations team and act as point of escalation for issue resolution.
• Ensure alignment of regional deliverables with overall study goals.
• Collaborate with key stakeholders in the region and provide regular updates on study progress.
• Generate, manage, and maintain high-quality study start-up and recruitment timelines for the region.
• Ensure timely availability of local adaptations of global study documents and submissions to regulatory authorities.
• Work closely with CRAs in the region to ensure proper study execution at sites.
• Handle escalated issues or problems with sites in the region.
• Monitor regional study activities for compliance with the study protocol, SOPs, and ICH-GCP.

Regional Clinical Study Manager

• Support and represent the Study Medical Manager throughout the clinical study lifecycle.
• Contribute to the development and review of key clinical documents, including protocols, protocol amendments, informed consent forms (ICFs), CRFs, and medical data validation plans.
• Perform medical review of patient data, listings, narratives, CIOMs, and clinical cases.
• Collaborate closely with Clinical Operations, Pharmacovigilance, Biostatistics, and Data Management teams to support data review and consistency checks.
• Review study-related documentation and contribute to interim analyses, Clinical Study Reports (CSRs), publications, and statistical outputs.
• Support the preparation and management of study committees, investigator meetings, and study training activities.
• Maintain medical and scientific documentation within the Trial Master File (TMF).
• Draft responses to medical questions from Health Authorities, Ethics Committees, investigators, and study teams.
• Develop medical review guidelines and support outsourced medical review activities when applicable.
• Contribute to audit and inspection readiness activities and support responses to findings.

Clinical Scientist – Immunology

• Support clinical trial activities from study start-up to close-out, ensuring adherence to standards.
• Contribute to the preparation and review of trial protocols and amendments.
• Perform medical review of clinical data, including patient profiles and adverse event narratives.
• Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review.
• Assist in medical writing and review of study-related documents.
• Ensure proper documentation and filing of study-related materials.
• Support preparation for audits, inspections, and regulatory submissions.

Clinical Research jobs in France

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Clinical Trial Manager

Regional Clinical Study Manager

Clinical Scientist – Immunology

Clinical Scientist