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Job #02500

About our client Our client is a biotechnology company focused on developing new treatments for under-served markets in oncology and infectious diseases. Position Location Clinical Project Manager Montreal, Quebec Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee all clinical aspects of specific phase I-III clinical studies 2) Work in close relationship with other departments (Preclinical, CMC, Regulatory, Statistics) 3) Oversee the external partners involved in the conduct/analysis of the study, particularly CROs 4) Prepare and execute protocol, data analysis, and report preparation 5) Liaise with clinical investigators and sites 6) Oversee the conduct of clinical studies with respect to budget, timelines, and related activities 7) Select and oversee the activities of CROs for the conduct of studies such as central laboratory, data management, statistics and monitoring (i.e. study guidelines, data management, etc.) 8) Prepare investigator’s meeting 9) Identify and select clinical investigators 10) Prepare and review protocols, consent forms, case report forms, final reports 11) Participate in data interpretation for clinical studies 12) Prepare the clinical part for regulatory submissions (CTA, IND, annual update, IB) in collaboration with Regulatory Affairs 13) Participate in clinical report writing and review 14) Review and implement SOPs 15) Participate in abstract and poster preparation Requirements 1) B. Sc. 2) 4+ years of experience in clinical research 3) Oncology experience preferred 4) Excellent knowledge and practice of ICH/GCP guidelines 5) Proficiency in computers (i.e. Word, Excel, and PowerPoint) 6) Excellent communication (English and French) 7) Superb leadership skills 8) Willingness to travel – up to 25-50%