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Senior Manager Clinical Trials

Reference Number: 3226
Location: NJ

Our client is a global pharmaceutical company.  They have asked us to assist them in their search for a Senior Manager, Clinical Trials.

Major tasks and responsibilities will include:

  • Manages and oversees the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.
  • Assists with the review and determination of appropriate site and vendor selection and ensuring all vendors meet the predetermined program milestones.
  • Interacts with internal and external groups (CROs, vendors, clinical sites, etc.) to facilitate clinical trials and achieve designated timelines.
  • Oversees study timelines, clinical trial budgets, coordinates development of study plans, CRF's and other study reports and reviews and approves monitoring reports as appropriate. Reviews CRO site monitoring calendars, tracks site visits, tracks monitoring report issuance and receipt, conducts initial reviews of reports, to assure that full internal reviews are conducted on a timely basis.
  • Oversees and participates in review of clinical trial data and clinical trial files. Provides clinical review of annual reports, IB updates.
  • Participates in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies.
  • Participates in special projects as appropriate.
  • Maintains professional and technical knowledge by staying current on pharmaceuticals industry research and developments as appropriate; by utilizing the resources made available by the Company; and by sharing information with colleagues.
  • Keeps management informed by escalating issues requiring intervention to the study and project teams.
  • Acts on constructive feedback by using feedback from peers, Supervisors, and colleagues to improve performance and ability to provide constructive feedback to direct reports and colleagues.

We seek candidates with the following qualifications:

  • Must have 7 - 10 years of experience and have extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP.
  • Must be familiar with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting.
  • Must have the ability to manage complex and global clinical trials.
  • Must be ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English. Ability to write reports, business correspondence and procedure manuals in English and have the ability to effectively present information to and respond to questions from groups of managers, sites, etc. Must have the ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Must have experience interfacing and managing multiple vendors/ contractors; and the ability to manage time, multi-task and prioritize in order to complete deliverables on schedule.

 

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 3226. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.