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Clinical Project Manager

2 months ago

Princeton, United States Intellectt Inc Full time

Role: Clinical Project Manager (Non-MD) - C

Location: Princeton, NJ - 8540

Duration: 12 Months


Shift Timings: 8am to 5pm


Responsibilities:

 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 out

activities.

 Monitors and reports progress of clinical studies and follows up with team

members and line managers when issues develop.

 Communicates and works with cross-functional teams to resolve issues that arise

during 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 statistics

would be an advantage as well as experience using the APOC i-STAT or equivalent

system.


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 vitro

diagnostics/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 and Abbott policies