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Clinical Project Manager

2 months ago

Princeton, United States Intellectt Inc Full time

Hello ,

One of my clients is looking Role: Clinical Project Manager, if you’re interested or your skills matches, please share with me your updated resume to sushma@intellectt.com


Note: Strictly Locals


Role: Clinical Project Manager

Location: Princeton, NJ

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 are an asset.
  • Knowledge of Good Clinical Practice and regulations governing in vitro diagnostics/medical devices are 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 policies