Clinical Data & Quality Manager

About the role

The Clinical Data & Quality Manager oversees Good Clinical Practice compliance across sponsored and partner-led clinical studies. This role focuses on ensuring data integrity, system qualification, and inspection readiness by working closely with clinical and data teams to embed compliance into workflows. You will manage deviations, CAPAs, and quality reviews while supporting regulatory adherence in a collaborative, agile environment.

Responsibilities

• Oversee study GCP compliance, manage deviations and 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.

Required skills

• ICH E6(R3)
• Annex 11
• 21 CFR Part 11
• CAPA
• CSV/CSQ
• ALCOA+
• EDC systems
• ePRO/eCOA
• GCP compliance

Nice to have

• ETL
• CDISC standards

Qualifications

• At least five years of relevant experience in Clinical Data Management and GCP compliance within a pharmaceutical company or CRO

About the Company

Resilience Care is a French company founded in 2021 that provides remote medical monitoring solutions in oncology, gastroenterology, and psychiatry. Their platform uses ePROs and AI technologies to optimize patient care and accelerate clinical research through the analysis of real-world data.