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Senior Manager Clinical Trials

Reference Number: 3225
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:

  • Accountable for the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) from study start up to study completion including relevant regulatory requirements.
  • Participates in the review and determination of appropriate site and vendor selection.
  • Ensures assigned clinical trials meet the predetermined program milestones.
  • Interacts with internal/ external groups (CROs, vendors, clinical sites, etc.).
  • Accountable for study timelines, clinical trial budgets, development of relevant study plans/documents.
  • Oversees monitoring report reviews and approval.
  • Reviews updates to annual reports, IB, etc. from the clinical trial prospective.
  • Responsible for Investigator Meeting coordination and participation,
  • Responsible for coordination of the review of clinical trial data.
  • 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.
  • Escalates issues as appropriate to the Associate Director.
  • Acts on constructive feedback to improve performance and provides feedback to direct reports and colleagues.
  • Responsible for the recruitment, training and development, performance management and resource management of staff.

We seek candidates with the following qualifications:

  • Must have 6 to 10 years of work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience. CNS experience is required.
  • Must have an 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 have the 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.
  • Must have the ability to effectively present information to and respond to questions from groups of managers, sites, etc. and the ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Must have demonstrated ability to work independently and in a team, and provide leadership in a management role.

 

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 3225. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.