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Job #02309

About our client Our client is a publicly traded company that creates novel medicines using unique, therapeutic peptides. The company, founded in the late '90s, is dedicated to the discovery of novel therapeutics with an initial focus on the treatment of diabetes. Position Location Clinical Project Manager Montreal, Quebec Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage investigational sites and service vendors with limited supervision 2) Select and contract negotiate with study centers and contract research organizations 3) Organize investigators’ meeting 4) Track and monitor site IRB approval 5) Maintain patient enrolment and treatment status 6) Plan monitoring schedule 7) Manage study drug accountability 8) Ensure the study is conducted as per ICH and GCP guidelines 9) Prepare study materials and documents, including clinical operations sections of protocol, informed consent templates, etc. 10) Review and analyze clinical data as needed for clinical study reports and other study documents in collaboration with clinical scientist 11) Prepare study budget and track spending 12) Maintain projects on track in terms of milestones and budget 13) Prepare and distribute regular clinical project updates 14) Plan and create presentations of clinical study information 15) Provide inputs in developing SOPs and training manuals for the clinical team Requirements 1) Bachelor's degree in a health-related discipline, or an R.N. nursing degree 2) 2-3 years of experience as a clinical project manager in a CRO or pharmaceutical company 3) Experience in type II diabetes clinical trials 4) Familiarity with clinical project management tools 5) In-depth knowledge of GCP/ICH guidelines 6) Understand clinical development and regulatory approval process 7) Excellent organizational and time management skills 8) Ability to prioritize and multi-tasks 9) Superb communication and interpersonal skills 10) Willingness to travel – up to 10-25%