Remote GCP & Data Quality Lead

Resilience Care; Grenoble; Remote; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Remote work in France

Job summary

Resilience Care in France is seeking a dedicated QARA professional to oversee Good Clinical Practice compliance across sponsored studies and studies conducted with pharmaceutical partners. You will combine clinical quality, data integrity and system qualification, working closely with teams running studies and building data workflows.

You will help keep studies inspection-ready, ensure data reliability and traceability, and embed compliance in everyday work.

Qualifications

• Minimum five years of relevant experience in Clinical Data Management and GCP compliance.
• Experience handling deviations, audits, inspections or procedures.
• Experience with computerised system qualification.
• Experience with EDC systems and ePRO/eCOA solutions.

Responsibilities

• Oversee study GCP compliance, manage deviations and CAPAs, and conduct TMF reviews.
• Maintain inspection readiness and support CRO oversight per ICH E6(R3).
• Qualify systems using CSV/CSQ and review data extractions and audit trails.
• Collaborate with Data and Clinical teams to embed compliance in data workflows.
• Train teams on clinical quality procedures and monitor regulatory developments.

Skills

GCP compliance

Quality management

Audits & CAPA

CSV/CSQ approaches

EDC/ePRO/eCOA systems

Regulatory documentation

English fluency

Tools

Medidata Rave

Veeva

Oracle

Job description

Resilience Care in France is seeking a dedicated QARA professional to oversee Good Clinical Practice compliance across sponsored studies and studies conducted with pharmaceutical partners. You will combine clinical quality, data integrity and system qualification, working closely with teams running studies and building data workflows.

You will help keep studies inspection-ready, ensure data reliability and traceability, and embed compliance in everyday work.