Remote GCP Compliance & Data Quality Lead

Resilience; Paris; Hybrid; EUR 65.000 - 95.000; Vollzeit

Benefits dieser Stelle

Remote work from France

Zusammenfassung

Resilience Care is seeking a qualified GCP/QA Compliance professional to oversee Good Clinical Practice across sponsored studies and partner trials. You will ensure data integrity, system qualification, and proper documentation while collaborating with clinical, data, and regulatory teams.

The role emphasizes preventing deviations, audits, and inspections readiness, with a focus on building compliant data workflows and quality practices. Remote work from France is possible."

Qualifikationen

• 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.

Aufgaben

• 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 DMPs.
• 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.

Kenntnisse

ICH E6(R3) Annex 11 & 21 CFR Part 11

GCP compliance

CAPA management

Audit readiness

Process improvement

English communication

Tools

Medidata Rave

Veeva

Oracle

Jobbeschreibung

Resilience Care is seeking a qualified GCP/QA Compliance professional to oversee Good Clinical Practice across sponsored studies and partner trials. You will ensure data integrity, system qualification, and proper documentation while collaborating with clinical, data, and regulatory teams.

The role emphasizes preventing deviations, audits, and inspections readiness, with a focus on building compliant data workflows and quality practices. Remote work from France is possible."