Oversees and resolves operational aspects of clinical trials in conjunction withproject teams and in accordance with standard operating procedures (SOP),good clinical practice (GCP) and specific country regulations.
Oversees development of clinical documents, including clinical plans, protocols,forms, and reports. Manages team to prepare for clinical study initiation, execution and close outactivities.
Monitors and reports progress of clinical studies and follows up with teammembers and line managers when issues develop.
Communicates and works with cross-functional teams to resolve issues that ariseduring clinical studies.
Ensures consistency of clinical study and processes across clinical trials.
Travels as necessary to aid in program facilitation.The position requires excellent communication skills, the ability to prioritize and work
independently. Exposure to basic Project Management methods, knowledge of statisticswould be an advantage as well as experience using the APOC i-STAT or equivalentsystem.
Qualifications
Post-secondary degree or diploma in Life Sciences, Biochemistry/Chemistry, Nursing, or equivalent..
5+ years experience in managing clinical studies or equivalent product development programs. Experience in in vitro diagnostic/medical device related studies is an asset.
Knowledge of Good Clinical Practice and regulations governing in vitrodiagnostics/medical devices is desirable.
Advanced skills in project planning and management, judgment, decision-making, and problem solving.
Working knowledge of new product development methodologies an asset.
Ability to be creative in achieving objectives while ensuring compliance to regulatory requirements
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Project Management and Information Technology
Industries
Human Resources Services
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