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Senior Manager, Clinical Operations - Neuroscience

Reference Number: 3191
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 Senior Manager, Clinical Operations – Neuroscience.

Major tasks and responsibilities will include:

  • 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.
  • Leads a pivotal Phase III global study for a major submission within the company's Neurology Business Group.
  • Oversees cross-functional alignment, budget and timeline from protocol generation through completion of clinical study report.
  • Manages all aspects of study progress from start-up to close-out activities to assuring 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, regulatory document filing.
  • Collaborates with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team.
  • Develops precise, accurate, timely and succinct written and verbal communications to provide peers and management with status updates, and escalating risks as appropriate.
  • Oversees 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 recognizing problem situations and informing 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:

  • A minimum of 5 years of experience in the pharmaceutical industry and know how to lead large global studies with multiple vendors that involve management of submission timelines and associated processes.
  • Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges is required.
  • This person must have a solid project and vendor management, analytical and problem solving skills.
  • Prior experience with development and tracking of study budgets in excess of $20M.
  • Experience with sleep disorder studies and Polysomnography (PSG) tests and electronic patient-reported outcome (ePRO) solutions are highly beneficial.

 

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 3191. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.