Clinical Data & Quality Lead – GCP Compliance

Resilience Care; Rennes; Remote; EUR 70,000 - 90,000; 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, is seeking a GCP/compliance specialist for its QARA team. You will oversee GCP compliance across sponsored studies, manage deviations and CAPAs, and ensure data integrity and regulatory readiness.

You’ll collaborate with clinical, data and CRO partners, qualify systems, review TMF and data management plans, and help embed quality into workflows while working remotely from France.

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 alone.
• 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 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 extrations, audit trails and Data Management Plans.

Skills

ICH E6(R3)

CAPA management

Audit preparation

EDC systems

ePRO/eCOA

English fluency

Tools

Medidata Rave

Veeva

Oracle

Job description

Resilience Care, a French company pioneering remote medical monitoring, is seeking a GCP/compliance specialist for its QARA team. You will oversee GCP compliance across sponsored studies, manage deviations and CAPAs, and ensure data integrity and regulatory readiness.

You’ll collaborate with clinical, data and CRO partners, qualify systems, review TMF and data management plans, and help embed quality into workflows while working remotely from France.