Clinical Scientist
il y a 3 jours
Cmed is seeking a PhD or PharmD Clinical Scientist with more 3 years of experience for this client dedicated opportunity. This position is fully remote.
You will support and represent the Study Medical Manager in all complex 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 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
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