Clinical Project Manager
Clinical Project Manager
TekOne IT Services Pvt. Ltd.
Princeton, NJ
See who TekOne IT Services Pvt. Ltd. has hired for this role
- 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.
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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