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Clinical Data Manager – France

10+ 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 Data Manager – France (Full-Time, Permanent Contract)

Excelya | Full-Time | Permanent | France

Excelya, a leading European CRO founded in 2014, specializes in innovative clinical research solutions. With a team of 800+ experts, we offer a one-stop provider model, collaborating across clinical operations, data management, and regulatory affairs.

At Excelya, we foster a dynamic and inclusive environment, ensuring team members can develop their expertise and contribute to impactful clinical research.

Position Overview

We are seeking an experienced Clinical Data Manager to oversee data management activities from study setup to database freeze. This role requires strong technical expertise, leadership in CRO supervision, and compliance with quality standards.

Key Responsibilities

  • Manage Data Management (DM) activities across multiple projects, ensuring timelines and quality standards are met.
  • Define and implement quality, security, and compliance standards to ensure data integrity.
  • Supervise and coordinate CRO interactions related to Data Management activities.
  • Review and approve study documents (e.g., Data Management Plan, Data Validation Plan, Data Review Plan).
  • Oversee Case Report Form (CRF) and eCRF design, including annotated CRF, database verification, and consistency tests.
  • Conduct data quality control, ensuring accurate data collection, validation, review, and reconciliation.
  • Ensure eTMF maintenance and compliance with ICH/GCP, regulatory guidelines, and ethical standards.
  • Represent Data Management in project meetings and contribute to CRO selection.
  • Support the development and updating of quality documents related to data management.

Required Skills & Qualifications

  • 10+ years of experience in Clinical Data Management, including 5+ years in eDC systems (Medidata Rave, TrialMaster, Ennov, Veeva Vault).
  • Strong expertise in DM processes (UAT, data cleansing, data review, reconciliation, data transfer management).
  • Experience in supervising CROs for clinical study data management.
  • Significant knowledge of CDISC (CDASH, SDTM) and coding dictionaries (MedDRA, WHODrug).
  • Experience in eCRF design and SAS programming is a plus.
  • Strong working knowledge of ICH/GCP guidelines and regulatory requirements.
  • Fluent in English (written & spoken).

Join Excelya and contribute to advancing clinical research with a team committed to excellence, integrity, and innovation.