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Job #03245

About our client Our client is a Canadian contract research organization that provides services like clinical research management and specialized assistance to pharmaceutical and biotechnology firms globally. Position Location Project Manager – Clinical Montreal, Quebec Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage, supervise, and coordinate all aspects of the clinical study to ensure that all client requirements are fulfilled 2) Act as the primary study contact for both internal/regional resources 3) Collaborate with developing study plans (monitoring, communication, safety, etc.), Investigator’s brochure, protocols, and protocol amendments (as appropriate) 4) Review/approve study-related documents including CRFs, informed consent form, etc 5) Review all monitoring reports 6) Plan/participate in investigators’ meetings and ensure the preparation of all presentation materials 7) Oversee the management of investigational product and all study materials 8) Manage the reporting of any serious adverse events (as required) as per the sponsor’s SOPs 9) Organize and chair Project Team meetings to communicate project objectives, timelines, and issues 10) Provide training/mentoring to clinical research associates (as required) 11) Ensure project-staffing requirements are met 12) Participate in corporate and resource planning initiatives/training (as required) Requirements 1) MS/BS in Health Sciences or RN 2) Clinical research experience in Phase 2 – 4 trials as a Senior Clinical Research Associate 3) In-depth knowledge of ICH/GCP 4) Superb leadership, customer service, organizational, and interpersonal skills 5) Proficiency in MS Office (Word, Excel, and Outlook) 6) Bilingual (French and English) 7) Willingness to travel nationally (up to 10%)