Clinical Data & Quality Manager

This is a fully remote position, open to applicants in France.

📋 Description

• Supervise adherence to Good Clinical Practice across sponsored studies and those conducted with pharmaceutical collaborators.

• Manage deviations and implement corrective and preventive actions (CAPAs).

• Perform quality assessments and conduct reviews of the Trial Master File (TMF).

• Ensure readiness for inspections and provide support for CRO oversight in alignment with ICH E6(R3).

• Validate systems and evaluate test environments.

• Review data extractions, audit trails, and Data Management Plans.

• Collaborate with Data and Clinical teams to integrate compliance into data workflows.

• Uphold clinical quality procedures.

• Train teams and keep abreast of regulatory developments.

• Work in conjunction with Clinical Operations, Clinical Scientists, Data and Translational Research, the DPO, CROs, and pharmaceutical partners.

• Protect clinical quality, data integrity, system qualification, and compliance, rather than directly producing data.

⛳️ Requirements

• Apply ICH E6(R3), Annex 11, and 21 CFR Part 11 in clinical studies and systems.

• Manage deviations, CAPAs, audits, and prepare for inspections.

• Qualify systems utilizing CSV/CSQ methodologies and implement ALCOA+ principles.

• Engage with EDC systems such as Medidata Rave, Veeva, or Oracle, as well as ePRO/eCOA solutions.

• Communicate and write proficiently in English.

• Maintain a rigorous approach that considers operational constraints.

• Demonstrate practical judgement to translate requirements into effective processes.

• Possess the ability to influence and train peers.

• Exhibit confidence in collaborating across clinical and technical teams and with external partners.

• Have a minimum of five years of relevant experience in Clinical Data Management and GCP compliance within a pharmaceutical organization or CRO.

• Experience managing deviations, audits, inspections, or procedures.

• Familiarity with contributing to computerized system qualification.

• Experience with EDC systems and ePRO/eCOA solutions.

• Understanding of pipelines, ETL, and databases is advantageous.

• Knowledge of CDISC standards for regulatory submissions is a plus.

🏝️ Benefits

• Work remotely from France.

• Connect with colleagues at internal company events.

• Contribute to dependable studies and data that support clinical research in oncology.

• Integrate clinical quality, data integrity, and collaboration with technical teams.