ARC Lead

Excelya>Full-time>ARC Lead

Job description

Founded in 2014, Excelya is a “people centered” contract research organization (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop provider service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.

You will be responsible for the follow-up and successful implementation of the Monitoring Plan as well as the management of the centers involving the launch, follow-up and closure of the studies. You will be the country point of contact for studies assigned within the Clinical Operations Department. You will be responsible for phase I to III studies in neurology, immunology and diabetes.

  • Ensure the follow-up of the studies related to the centers, including (evaluation, selection, activation, follow-up and site closure)
  • Anticipate and identify study related issues that could affect timelines and propose alternative solutions
  • Maintain up-to-date clinical trial management systems containing all study specific information
  • Ensure expertise in local regulatory and legal requirements
  • Ensure study budget monitoring at the local level
  • Prepare and make regulatory submissions (initial and amendments) to the ANSM and the Ethics Committee
  • Ensure compliance with applicable local regulations, Good Clinical Practices (GCP), ICH guidelines, Standard Operating Procedures (SOP), Monitoring Plan and other applicable study plans, and quality standards in the conduct of clinical research
  • Ensure audit and inspection preparation of studies at the French level: Advise on pre-audit activities for GCP requirements. Prepare and follow up audits/inspections of centers. Contribute to the preparation of the CAPA
  • Coach and mentor CRAs and contribute to their development
  • Be the primary point of contact for RCOs on assigned studies at the local level
  • Participate/lead local task forces and initiatives

Profile

  • Higher scientific education (BAC+5)
  • At least 3 years experience in monitoring international clinical trials in the pharmaceutical industry
  • A notable and recent experience in the field of oncology
  • Knowledge of the following systems: Knowledge of the following systems: IWRS, RAVE electronic notebook, ePRO
  • Knowledge of Risk-Based Monitoring (remote visit, CDM)
  • Fluency in written and spoken English.

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