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Clinical Research Project Manager

2 weeks ago

Montreal, Quebec, Canada Research Institute of the MUHC Full time


Job Description

RESEARCH INSTITUTE OF THE MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Position summary
Under the supervision of the Manager, Pediatric & Adult Research, at the Centre for Innovative Medicine (CIM) as well as following established governmental guidelines and regulations, the incumbent is responsible for the management of a multicenter clinical research study.

General Duties

• Manages site feasibility questionnaire and qualification visits,

• Ensures start-up activities, including site initiation,

• Customizes study material for Canada,

• Prepares and provide site training,

• Primary liaison to clients, ensuring questions is answered and issues are resolved,

• Primary liaison to biostatistician to ensure analysis of research questions are appropriately addressed,

• Oversees project timelines and patient accrual,

• Prepares and ships study materials to sites,

• Follows-up on recruitment activities according to study timelines,

• Manages other study activities such as monitoring visits, data management and statistics deliverables,

• Follows-up on regulatory activities,

• Prepares newsletters for sites,

• Manages payment to sites,

• Manages the study budget,

• Conducts and coordinates the meeting with sponsor and other stakeholders,

• Responsible for follow-up meetings with sponsor,

• Provides regular status report to sponsor,

• Offers support to sites,

• Other duties as assigned by the supervisor.



Website of the organization

Education / Experience


• Education: Bachelor's degree in Health Science or a related field,

• A minimum of 2 years in multicenter clinical trial management or national registries for clinical research,

• Experience in the pharmaceutical industry combined with hospital environment is preferred.



Required Skills


• Bilingual (Excellent verbal and written communication skills in French and English),

• Working knowledge of project and budget management,

• Clinical research accreditation is preferred,

• Excellent organizational skills,

• Ability to manage multiple priorities, and prioritizing for time-sensitive issues,

• Excellent knowledge of international, federal and provincial laws and regulations governing clinical research (ICH-GCP),

• Self-directed and organized. Able to work both independently and as part of a team,

• Excellent interpersonal skills,

• Basic knowledge of biostatistics and Data management is preferred,

• Proficient with technology systems (EDC, MS Excel, Power Point, etc.).