Clinical Research Physician

Founded in 2014, Excelya is a 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.

Main activities:
We are looking for a clinical research physician to work as a consultant for one of our partners who is a major player in the pharmaceutical industry.
You will be involved in international studies in oncology, you will have the following missions

• Participation in the writing of documents related to the trials: synopsis, protocol, consent, amendments, medical data validation plans, answers to medical questions, contribution to various meetings (investigators, monitors, etc.), management of study committees.
• Medical review of patient profile data, listings and CIOMs. Writing of guidelines for collaboration with China.
• Close collaboration with Trial Operations, pharmacovigilance (CME/GSO) and statistics for the implementation of listings necessary for data consistency review.
• Review of study documents: CRF, validation plan, disclosure form…
• Participation in the review of interim and final study reports, associated statistical tables and publication drafts.
• Medical review of files, review of medical listings and participation in the management of clinical studies (protocol writing, clinical baseline analysis, study set-up, medical training, medical responses) in the field of global medical affairs studies regardless of the therapeutic area and type of phase 3B and 4 studies.
• Medical review and guidelines for medical reviews in the context of outsourcing