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FTC Clinical Trial Manager

  • Location: France
  • £ Salary: Negotiable per year
  • Job Type:Permanent

Posted 16 days ago

  • Sector: Clinical Operations
  • Contact: Antonia Ray
  • Duration: 9-12 months
  • Start Date: ASAP
  • Expiry Date: 12 March 2024
  • Job Ref: JN -022024-483680

Main Responsibilties

  • Managing clinical trials from startup to close out, to ensure compliance with trial protocol and in accordance with scope of work/budget, local laws, international guidelines (ICH-GCP) and applicable SOPs.
  • Responsible for the day-to-day operations and oversight of clinical trials including but not limited to status, patient recruitment, risk management, timelines, budget, safety and quality.
  • Monitoring the progress of clinical trials, proactively identify deficiencies or risks, and implement mitigation strategies/CAPAs to ensure study timelines and objectives are achieved.
  • Manage and be the main point of contact for the internal and external (CRO, External Service Providers) teams.
  • Responsible for the trial budget, accruals, forecasts in collaboration with Finance.
  • Develop and/or review trial specific plans and documents.
  • Preparing regular status updates on the clinical trials to senior management.
  • Oversight of all trial files, including the Trial Master File, ensuring completeness for audit/inspection readiness, and investigator site files.

Required Skills & Experience

  • Bachelor's or Master's degree in a scientific or healthcare-related field (e.g., Life Sciences, Biotechnology, Nursing, Pharmacy).
  • Experience with the management of ESPs and Third-Party Vendors/Central Labs.
  • Solid experience working with electronic data capture systems, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).
  • Thorough understanding of relevant regulatory requirements, legislations and international guidelines (ICH-GCP).
  • Very strong project management skills.
  • Self-motivated way of working and "hands-on" and "can-do" attitude.
  • Detail-oriented and well-organized: can prioritize multiple tasks and goals.
  • Strong critical thinking and problem-solving skills.
  • Fluent in both written and spoken English. Any additional language is a plus!
  • Very good knowledge of MS Office packages and Google Workspace.