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Manager Clinical Operations

Reference Number: 2773
Location: NJ

Our client is a global pharmaceutical company addressing unmet medical needs.  They have asked us to assist them in their search for a Manager Clinical Operations.

The Manager Clinical Operations is responsible for the overall management of clinical studies in multiple Phases including, but not limited to, the development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filing.  The incumbent will work with other team members to coordinate preparation of study protocols and final study reports.  This position requires a detailed understanding of overall strategic direction; interrelationships and business needs.

Major tasks and responsibilities will include:

  • Manages all aspects of study progress from start-up to close-out activities to assure adherence to intended timeline to achieve study goals while ensuring good clinical practice compliance in accordance with FDA, GCP, and ICH guidelines.
  • Coordinates interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, and regulatory document filing.
  • Collaborates with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team.
  • Oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality.
  • Communicates with study sites, proactively recognizes problem situations and informs team members to enable issue resolution.
  • Contributes to individual and team development through training initiatives and team building activities.

We seek candidates with the following qualifications:

  • Bachelor’s degree in biological science, nursing, pharmacy or equivalent.
  • Minimum of 5 years of experience in the pharmaceutical industry in a position performing clinical operations functions.
  • Global experience is a plus with respect to clinical research activities.
  • Experience with oncology is required.
  • Electronic data capture experience, particularly Inform, is a plus.
  • Strong communication skills.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2773. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.