GCP & Data Quality Manager (Remote)

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

Job summary

Resilience Care, a French company advancing remote medical monitoring, seeks a GCP/compliance specialist to safeguard regulatory integrity across sponsored studies and partner projects. You will oversee deviations, audits, and TMF readiness while collaborating with Clinical Operations and Data teams.

You will join an agile QARA team reporting to Yasmine, contributing to data integrity and quality assurance within a modern remote work setup in France.

Qualifications

• Must apply ICH E6(R3), Annex 11 and 21 CFR Part 11 to studies and systems.
• Experience handling deviations, CAPAs, audits and inspection preparation.
• Qualify systems using CSV/CSQ approaches and ALCOA+ principles.
• Work with EDC and ePRO/eCOA solutions, translating requirements into controls.
• Fluent English communication (written and spoken).

Responsibilities

• Oversee GCP compliance across studies and TMF reviews.
• Maintain inspection readiness and CRO oversight alignment.
• Qualify systems, review test environments and data management plans.
• Collaborate with Data and Clinical teams to embed compliance in workflows.
• Train teams and monitor regulatory developments.

Skills

ICH E6(R3)

Deviations & CAPA

Audits & inspection prep

CSV/CSQ systems qualification

E C D C systems & ePRO/eCOA

English communication

Tools

Medidata Rave

Veeva

Oracle

Job description

Resilience Care, a French company advancing remote medical monitoring, seeks a GCP/compliance specialist to safeguard regulatory integrity across sponsored studies and partner projects. You will oversee deviations, audits, and TMF readiness while collaborating with Clinical Operations and Data teams.

You will join an agile QARA team reporting to Yasmine, contributing to data integrity and quality assurance within a modern remote work setup in France.