Clinical Research Physician

Excelya>Full-time>Clinical Research Physician

Description de l'emploi

Established 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-shop 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.

 

Mission:

Reporting to the Medical Director, the Clinical Research Physician F/M develops and drafts study protocols, presents them to the various internal and external stakeholders and is the medical referent on its projects.

Main Activities

  • Responsibility and monitoring of clinical activities:
  • Participate in regulatory submissions and discussions with health authorities / ethics committee in conjunction with the regulatory department;
  • Review or drafting of supporting documents for the clinical study (protocol, investigator brochure and inform consent form, case report form and patient diary, etc.);
  • Review and validation of clinical data during the study and coordination of data analysis;
  • Control of the progress of clinical studies;
  • Management of subcontracting activities related to the production of clinical study reports;
  • Control and validation of clinical study reports and publications of clinical study results;
  • Responsible of the quality of clinical documents according to international standards and internal procedures
  • Establishment and animation of networks of investigators and opinion leaders;
  • Presentation of clinical development projects to health authorities, investigators, opinion leaders and congresses;
  • Review and follow-up of adverse events, review of narratives (initial/follow-up), write or review annual safety reports

Profile:

  • State Diploma of Doctor of Medicine or PhD or equivalent
  • At least 5 years of experience in a similar position
  • Significant experience in a health industry: biotech, pharmaceutical industry, health industry provider, etc.
  • Expertise in a rare disease and/or in gene therapy would be a plus
  • Good level in English
  • Based in Paris or Montpellier

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