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Clinical Monitor Lead – France

5+ years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Monitor Lead – France

Excelya | Full-time | Permanent Contract | Paris, France

Excelya is seeking a Clinical Monitor Lead to oversee and manage clinical research activities while ensuring compliance with Good Clinical Practice (GCP) and ICH regulations. This role involves CRO coordination, site monitoring, and study documentation management to ensure high-quality clinical trials.

Key Responsibilities

Study Start-up & Oversight

  • Oversee the Clinical CRO team and work closely with cross-functional teams for study setup.
  • Support training of CRAs on study-specific activities.
  • Assist in defining timelines and milestones for clinical studies.
  • Validate final clinical study documents.

Monitoring & Compliance

  • Review site visit reports as per the Oversight Monitoring Plan and ensure timely resolution of issues.
  • Conduct co-monitoring visits, verify data integrity, and support investigator sites.
  • Participate in ongoing clinical data reviews with study teams.
  • Maintain compliance with clinical trial tracking systems (CTMS).

CRO & Investigator Relationship Management

  • Coordinate and manage CRO relationships.
  • Support in audit/inspection preparation and follow-up.
  • Ensure adherence to agreed timelines for data collection and query resolution.

Documentation & Reporting

  • Maintain clinical study documentation for study setup, maintenance, and closure.
  • Conduct TMF (Trial Master File) quality reviews throughout the study.
  • Participate in financial tracking and study system setup (IWRS, IMP forecasting, etc.).

Minimum Requirements

  • Scientific degree (Bac +5) + Clinical Research Associate (CRA) training.
  • 5+ years of experience as a Field CRA Monitor.
  • Experience in clinical study documentation and CRO relationship management.
  • Strong knowledge of Good Clinical Practice (GCP) & ICH regulations.
  • Team player with strong interpersonal & organizational skills.

📍 Location: Paris Area, France