Remote GCP & Data Quality Lead

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

Benefits offered by this job

Remote work from France

Job summary

Resilience Care in Paris region seeks a QARA professional to oversee GCP compliance across sponsored studies and partner projects. You will ensure data integrity, system qualification and regulatory alignment, working with Clinical Operations, Data, and CROs.

You will maintain inspection readiness, manage deviations and CAPAs, and qualify computerised systems while supporting external partners and teams. This role emphasizes governance over data production and quality assurance.

Qualifications

• Five+ years of relevant experience in Clinical Data Management and GCP compliance.
• Experience with deviations, CAPAs, audits or inspections.
• Experience with computerised system qualification.
• Experience with EDC/ePRO/eCOA solutions.
• Fluent 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 using CSV/CSQ approaches and review 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

Quality management

Regulatory standards

E2E QA processes

English fluency

Tools

Medidata Rave

Veeva

Oracle

Job description

Resilience Care in Paris region seeks a QARA professional to oversee GCP compliance across sponsored studies and partner projects. You will ensure data integrity, system qualification and regulatory alignment, working with Clinical Operations, Data, and CROs.

You will maintain inspection readiness, manage deviations and CAPAs, and qualify computerised systems while supporting external partners and teams. This role emphasizes governance over data production and quality assurance.