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Local Study Manager – France

3-6 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

Local Study Manager – France (Full-Time, Permanent)

Excelya | Full-Time | Permanent | France

Excelya, a leading European Contract Research Organization (CRO), is looking for a Local Study Manager (LSM) to lead, coordinate, and oversee clinical trials in oncology for one of the world’s largest pharmaceutical companies. This role involves managing study operations, ensuring regulatory compliance, and leading a team of Clinical Research Associates (CRAs) to ensure the timely and high-quality execution of trials.

Key Responsibilities

  • Lead and oversee local clinical trials from setup to closure in an international environment.
  • Prepare essential clinical study documents and ensure compliance with regulatory requirements.
  • Manage study timelines and budgets to meet project goals efficiently.
  • Select and manage trial sites and subcontractors to ensure high performance.
  • Coordinate activities to optimize patient recruitment and trial execution.
  • Ensure study results are delivered with high quality, on time, and within budget.
  • Handle regulatory submissions and administrative follow-ups in accordance with GCP (Good Clinical Practice) and internal procedures.
  • Conduct feasibility studies and participate in the selection of investigators.
  • Lead and support a team of Clinical Research Associates (CRAs) for effective study execution.

Minimum Requirements

  • 3 to 6 years of experience in the pharmaceutical industry, with a focus on clinical trial management (operational & budgetary).
  • Prior experience in oncology or tumor biomarkers is required.
  • Strong leadership, communication, and organizational skills.
  • A team-oriented mindset with the ability to work in a dynamic environment.
  • Proficiency in English and strong scientific knowledge.

This is an exciting opportunity to lead cutting-edge oncology clinical trials, collaborate with global teams, and drive impactful research that enhances patient care.