Safety Contract Manager

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

Represent the Clinical Research Physician and take on certain medical/scientific activities related to clinical trials by delegation which may include the activities listed below:
– Participation in the drafting of trial-related documents: consent, amendments, medical data validation plans, answers to medical questions, contribution to various meetings (investigators, monitors, etc.), management of study committees
– Medical review of data and collaboration with Pharmacovigilance (PV) / Clinical Operations for data consistency review
– Review of study documents, review and medical validation of data.
– Participate in the review of final study reports, associated statistical tables and draft publications
– Electronic filing and archiving of documents
– Medical chart reviews, medical listing reviews and participation in clinical study management (clinical baseline analysis, study set-up, training, medical process issues) in the area of global studies
– Reviewed and finalized medical records, clarified and validated medical report data, contributed to meetings and answered questions provided
– Medical review and guidelines for medical reviews in the context of outsourcing drafted


Minimum Requirements :

Scientific background BAC +5 or Ph.D
Experience in clinical project management or a similar position of at least 5 years in international clinical trials in oncology
Fluent in English
Mobility in France (remote accepted)



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