Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations.
- Manages team to prepare for clinical study initiation, execution and close out activities.
- Excellent communication skills, the ability to prioritize and work independently.
- Travels as necessary to aid in program facilitation.
- Ensures consistency of clinical study and processes across clinical trials.
- Exposure to basic Project Management methods, knowledge of statistics would be an advantage as well as experience using the APOC i-STAT or equivalent system.
- Oversees development of clinical documents, including clinical plans, protocols, forms, and reports.
- Communicates and works with cross-functional teams to resolve issues that arise during clinical studies.
- Monitors and reports progress of clinical studies and follows up with team members and line managers when issues develop.
- Post-secondary degree or diploma in Life Sciences, Biochemistry/Chemistry, Nursing, or equivalent.
- Advanced skills in project planning and management, judgment, decision-making, and problem solving.
- 6+ 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 vitro diagnostics/medical devices is desirable.
- Working knowledge of new product development methodologies an asset.
- Ability to be creative in achieving objectives while ensuring compliance to regulatory requirements and Abbott policies.
Vacancy Type: Full Time
Job Location: Toronto, Ontario, CA
Application Deadline: N/A