Clinical Data & Quality Manager

Job not on LinkedIn

🔥 0 minutes ago

🇫🇷 France – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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Resilience

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2020

🏭 Manufacturing

🏥 Healthcare

📦 Logistics

Manufacturing • Healthcare • Logistics

Resilience is a leading biomanufacturing innovation company focused on the development of novel medicines. Specializing in the manufacturing of complex medicines such as cell and gene therapies, Resilience partners with small and mid-sized biotech firms to provide customized solutions that leverage cutting-edge technologies and scientific advancement. Their approach includes high-tech, end-to-end drug substance and drug product manufacturing capabilities aimed at ensuring rapid, safe, and scalable production. Resilience operates primarily in North America, with expertise in delivering regulatory-compliant solutions across global markets, enhancing the reliability and accessibility of biopharmaceutical supply chains.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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