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Clinical Project Manager/Associate Director Clinical Operations

Reference Number: 3697
Location: MA

Our client is a clinical-stage biotechnology company. They have asked us to assist them in their search for a Clinical Project Manager/Associate Director, Clinical Operations.

Major tasks and responsibilities will include:

  • Participates in review and development of study protocols, study level plans, Investigator’s Brochures, informed consents and other study related documentation.
  • Participates in CRO and vendor selection. Leads CRO and vendors in the execution of clinical studies.
  • Oversees site selection and study start up. Attends site initiation meetings or other site visits as needed.
  • Oversees clinical monitoring and reviews/approves monitoring trip reports.
  • Oversees development of case report forms, data management plans, edit check specifications and data transfer plans.
  • Oversees and coordinates review of statistical analysis plans, data monitoring committee charters, and study results.
  • Oversees development of and execution of the safety management plan.
  • Collaborates with the Medical Director to develop a medical monitoring plan.
  • Collaborates with CMC for clinical supplies packaging, labelling, and distribution.
  • Reviews study level tracking.
  • Participates in study level financial tracking and budget review.
  • Participates in data review in preparation for regulatory submissions, posters, publications and presentations. Authors and reviews clinical sections of regulatory submissions.
  • Participates in risk assessment to avoid unnecessary risk and executes risk mitigation plans.
  • Maintains study master files.
  • Participates in development of departmental policy and process.
  • Assists team with travel logistics, meeting planning, and slide preparations as needed.

We seek candidates with the following qualifications:

  • Requires a Bachelor’s degree.  Master’s Degree preferred.
  • Must have 5+ years of experience in clinical trial management in a CRO, pharmaceutical, or biotech company.
  • Requires medical and scientific communication skills, both written and oral.
  • Must have the demonstrated ability to develop complex reports, schedules, correspondence, and other administrative documents.
  • Requires experience handling sensitive and confidential business matters and information with discretion.
  • Must be able to work collaboratively across organizations.   
  • Requires the ability to travel as necessary (approximately 25%)

If interested, please email your resume as a Word attachment to us, reference 3697.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.