Remote GCP & Data Quality Manager

Resilience Care

Montpellier

Remote

EUR 70,000 - 110,000

Full time

31 hours ago
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Benefits offered by this job

Remote work from France

Job summary

Resilience Care in France is seeking a GCP Compliance Lead to oversee Good Clinical Practice across sponsored studies and pharmaceutical collaborations. You will ensure data integrity, regulatory alignment and system qualification while collaborating with clinical and technical teams.

You will drive inspection readiness, manage deviations and CAPAs, and support CRO oversight in line with ICH guidelines. This role blends quality, data management and cross-functional coordination to safeguard

Qualifications

  • Minimum five years of experience in Clinical Data Management and GCP compliance.
  • Experience handling deviations, audits, inspections, and TMF reviews.
  • Familiarity with EDC systems and data management processes.
  • Ability to translate regulatory requirements into practical controls.
  • Strong written and spoken English.

Responsibilities

  • Oversee GCP compliance across sponsored studies and partner studies.
  • Manage deviations, CAPAs, audits and inspection readiness.
  • Qualify systems using CSV/CSQ approaches and apply ALCOA+.
  • Collaborate with Data, Clinical Operations and CROs to embed compliance in workflows.
  • Train teams on clinical quality procedures and monitor regulatory developments.

Skills

GCP Compliance
Data Integrity
Quality Management
Regulatory Audits
Quality Systems
English Fluency
Cross-functional Collaboration

Education

Master's degree in Life Sciences (preferred)

Tools

Medidata Rave
Veeva
Oracle EDC
CSV/CSQ methodologies

Job description

Resilience Care in France is seeking a GCP Compliance Lead to oversee Good Clinical Practice across sponsored studies and pharmaceutical collaborations. You will ensure data integrity, regulatory alignment and system qualification while collaborating with clinical and technical teams.

You will drive inspection readiness, manage deviations and CAPAs, and support CRO oversight in line with ICH guidelines. This role blends quality, data management and cross-functional coordination to safeguard

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