Remote Senior GCP & Data Quality Manager

Resilience Healthcare L.L.C.; Paris; Remote; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Remote work from France

Job summary

Resilience Care is seeking a dedicated GCP compliance professional to oversee Good Clinical Practice across sponsored studies and partner trials. You will blend clinical quality, data integrity, and system qualification, collaborating with study teams to embed compliance into data workflows.

This remote role from France focuses on inspection readiness, CAPAs, and continuous improvement within QARA, reporting to Yasmine and engaging with CROs and partners to ensure compliant operations.

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 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 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

Clinical Data Management

Quality management

English fluency

Tools

Medidata Rave

Veeva

Oracle

ePRO/eCOA

Job description

Resilience Care is seeking a dedicated GCP compliance professional to oversee Good Clinical Practice across sponsored studies and partner trials. You will blend clinical quality, data integrity, and system qualification, collaborating with study teams to embed compliance into data workflows.

This remote role from France focuses on inspection readiness, CAPAs, and continuous improvement within QARA, reporting to Yasmine and engaging with CROs and partners to ensure compliant operations.