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.
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 workindependently. Exposure to basic Project Management methods, knowledge of statisticswould be an advantage as well as experience using the APOC i-STAT or equivalent system.
Qualifications
To be considered for this position, you will have the following education, skills, and abilities:
Post-secondary degree or diploma in Life Sciences, Biochemistry/Chemistry,Nursing, or equivalent..
5+ years experience in managing clinical studies or equivalent productdevelopment programs. Experience in in vitro diagnostic/medical device relatedstudies 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 toregulatory requirements and Abbott policies
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Project Management and Information Technology
Industries
Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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Senior Project Manager, Global Clinical Drug Supply - Strategy & Innovation – (Advanced Proficiency in Speaking and Writing in Chinese (Simplified) Required) - Hybrid