Clinical Data & Quality Manager

• Oversee Good Clinical Practice compliance across sponsored studies and studies conducted with pharmaceutical partners
• Manage deviations and corrective and preventive actions (CAPAs)
• Conduct quality and Trial Master File (TMF) reviews
• Maintain inspection readiness and support CRO oversight in line with ICH E6(R3)
• Qualify systems and assess test environments
• Review data extractions, audit trails and Data Management Plans
• Work with Data and Clinical teams to build compliance into data workflows
• Maintain clinical quality procedures
• Train teams and monitor regulatory developments
• Work with Clinical Operations, Clinical Scientists, Data and Translational Research, the DPO, CROs and pharmaceutical partners
• Safeguard clinical quality, data integrity, system qualification and compliance rather than produce data directly

• Apply ICH E6(R3), Annex 11 and 21 CFR Part 11 to clinical studies and systems
• Manage deviations, CAPAs, audits and inspection preparation
• Qualify systems using CSV/CSQ approaches and apply ALCOA+ principles
• Work with EDC systems such as Medidata Rave, Veeva or Oracle, and ePRO/eCOA solutions
• Communicate and write fluently in English
• Rigorous approach that takes operational constraints into account
• Practical judgement to turn requirements into workable processes
• Ability to influence and train colleagues
• Confidence working across clinical and technical teams and with external partners
• At least five years of relevant experience in Clinical Data Management and GCP compliance within a pharmaceutical company or CRO
• Experience handling deviations, audits, inspections or procedures
• Experience contributing to computerised system qualification
• Experience with EDC systems and ePRO/eCOA solutions
• Understanding of pipelines, ETL and databases is a plus
• Knowledge of CDISC standards for regulatory submissions is a plus

• Work remotely from France
• Meet colleagues at internal company events
• Contribute to reliable studies and data supporting clinical research in oncology
• Combine clinical quality, data integrity and collaboration with technical teams