[Hiring] Clinical Data & Quality Manager @Resilience Care

Role Description

Within QARA, you oversee Good Clinical Practice compliance across Resilience’s sponsored studies and studies conducted with pharmaceutical partners. You combine clinical quality, data integrity and system qualification, working closely with the teams running studies and building data workflows.

Your impact:

• Help keep studies inspection-ready, data reliable and traceable, and compliance embedded in everyday work.
• Safeguard the framework and help teams apply it, rather than produce the data yourself.

Your day-to-day work:

• Oversee study GCP compliance, manage deviations and corrective and preventive actions (CAPAs), and conduct quality and Trial Master File (TMF) reviews.
• Maintain inspection readiness and support CRO oversight in line with ICH E6(R3).
• Qualify systems, assess test environments and review data extractions, audit trails and Data Management Plans.
• Work with Data and Clinical teams to build compliance into data workflows from the outset.
• Maintain clinical quality procedures, train teams and monitor regulatory developments.

This is not a site-monitoring, data-engineering, study-project-management or routine clinical data-production role.

Qualifications

• Apply ICH E6(R3), Annex 11 and 21 CFR Part 11 to clinical studies and systems.
• Manage deviations, CAPAs, audits and inspection preparation, beyond data cleaning alone.
• Qualify systems using CSV/CSQ approaches and apply ALCOA+ principles.
• Work with EDC systems and ePRO/eCOA solutions, translating their requirements into practical controls.
• Communicate and write fluently in English.

Requirements

• A rigorous approach that takes operational constraints into account.
• Practical judgement to turn requirements into workable processes.
• The ability to influence and train colleagues rather than impose rules.
• Confidence working across clinical and technical teams and with external partners.

Benefits

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

Recruitment Process

• Initial conversation with Elena.
• Interview with Yasmine, your future manager.
• Case study with Sarah and Yasmine from QARA.
• Team conversation with Nicoleta, Bertille and Alric.
• Strategic interview with Raph.