Remote GCP Compliance & Clinical Data Quality Lead

Resilience Care; Lyon; Remote; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Remote work from France

Job summary

Resilience Care in France seeks a GCP/compliance specialist within QARA to ensure Good Clinical Practice across sponsored studies and partner trials. You combine clinical quality, data integrity and system qualification, working with study teams to embed compliance into data workflows.

You will keep studies inspection-ready, support CRO oversight, qualify systems, review audit trails, and help teams apply ALCOA+ principles, eDC/ePRO solutions, and regulatory standards.

Qualifications

• Apply ICH E6(R3), Annex 11 and 21 CFR Part 11 to clinical studies and systems.
• Manage deviations, CAPAs, audits and inspection preparation, beyond data cleaning.
• Qualify systems using CSV/CSQ approaches and apply ALCOA+ principles.
• Work with EDC systems and ePRO/eCOA solutions, translating their requirements into practical controls.
• Communicate and write fluently in English.

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 DM 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

ICH E6(R3) & Part 11

CAPA management

CSV/CSQ qualification

EDC/ePRO expertise

English fluency

Tools

Medidata Rave

Veeva

Oracle

Job description

Resilience Care in France seeks a GCP/compliance specialist within QARA to ensure Good Clinical Practice across sponsored studies and partner trials. You combine clinical quality, data integrity and system qualification, working with study teams to embed compliance into data workflows.

You will keep studies inspection-ready, support CRO oversight, qualify systems, review audit trails, and help teams apply ALCOA+ principles, eDC/ePRO solutions, and regulatory standards.