Clinical Data Quality & Compliance Lead

Resilience Care; Biarritz; Remote; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Remote work from France

Internal company events

Job summary

Resilience Care, a French company pioneering remote medical monitoring and clinical research, seeks a Compliance Lead for Good Clinical Practice across sponsored studies. You combine clinical quality, data integrity and system qualification while partnering with study teams and data workflows.

You ensure studies remain inspection-ready, data remains traceable, and regulatory requirements are embedded in everyday work.

Qualifications

• Five years of experience in Clinical Data Management and GCP compliance.
• Experience with regulatory inspections and audits.
• Experience with computerised system qualification.
• Familiar with EDC systems and ePRO/eCOA solutions.

Responsibilities

• Oversee study GCP compliance, manage deviations and CAPAs, and conduct quality and 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.

Skills

GCP compliance

ICH E6(R3)

CAPAs & deviations

Audit readiness

EDC systems knowledge

Tools

Medidata Rave

Veeva

Oracle

Job description

Resilience Care, a French company pioneering remote medical monitoring and clinical research, seeks a Compliance Lead for Good Clinical Practice across sponsored studies. You combine clinical quality, data integrity and system qualification while partnering with study teams and data workflows.

You ensure studies remain inspection-ready, data remains traceable, and regulatory requirements are embedded in everyday work.