Clinical Scientist (Remote)

I. Excelya

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 900 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 journ 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.

II. Mission

Support and represent the Study Medical Manager in all oncology study related activities from set up to closure.

• Contribution to the documents elaboration relating to the trials: abbreviated protocol, protocol, informed consent (ICF), protocol and ICF amendments, medical data validation plans, answers to medical questions, contribution to various meetings (investigators, monitors, etc.), management of study committees’ preparation.

Medical review of data on patient profiles, listings and CIOMs.

• Close collaboration with Trial Operations (TO), pharmacovigilance (CME / GSO) and statistics for the establishment of the listings necessary for the review of data consistency.
• Review of study related documents: CRF, CRF completion instructions, deviations list, validation plan, protocol review form, …
• Contribution to the review of interim and final studies reports, associated statistical tables and draft publications.
• Medical review of files, reviews of medical listings and contribution to the management of clinical studies (writing of protocols, basic clinical analysis, study set-up, medical training, medical responses) in the field of oncology studies, regardless of the type of study.
• Medical review and Guidelines to be written for medical reviews in the context of outsourcing or whenever applicable (Working language and document writing in English)

III. Profile

You have a PhD or a Pharma D. You justify of 3 years on a similar position or different position in different clinical research positions. You speak a fluent English.