Société : Excelya Lieu : Saint-Martin (France) 97150
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Support and represent the Study Medical Manager in all oncology study-related activities from set up to closure.
~ Contribution to the elaboration of the document 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.), 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.
~ 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 Fluency in French & good level in English Excelya Saint-Martin(France)97150 Autre(s) VIE 0 mois
