What are the responsibilities and job description for the Clinical Project Manager position at TekOne IT Services Pvt. Ltd.?
Role: Clinical Project Manager (Non-MD) - C
Location: Princeton, NJ - 8540
Duration: 12 Months
Responsibilities
Location: Princeton, NJ - 8540
Duration: 12 Months
Responsibilities
- 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.
- 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
