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Clinical Operations Manager - Boston, MA

Industry: Life Sciences

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Clinical Operations Manager - Boston, MA
 
My client, a rapidly growing biopharmaceutical company, located in the Boston area is actively looking for a Clinical Operations Manager to join their expanding clinical team.

Description:

This expansion position will provide support on all aspects of clinical operations management and planning. The Manager will ensure best practices for monitoring the progress of the study in adherence with the projected timelines, budget and quality of study data in accordance with GCP.

The ideal candidate must be able to travel up to approximately 30% of the time. The Clinical Operations Manager will support planning activities as part of the required start-up tasks for Phase 1 through Phase 3 clinical research studies, and will:

  • Assist in the selection, contracting and management of Contract Research Organizations
  • As part of the project team participate in site identification, assessment and identification of high quality and productive investigative sites
  • Supports coordination of activities of clinical team and external CRO to ensure study deliverables in a timely manner
  • Facilitates optimal communication, documentation and reporting within the clinical trial team and towards management
  • Supports preparation and review of study specific-documents (e.g. protocol, CRF, study report etc)
  • Build strong relationships with investigative sites and CRO personnel via multiple channels, including co-monitoring of investigative sites
  • Monitor and/or co-monitor selected investigative sites
  • Interacts with investigative site staff, including, clinical investigators and site coordinators, to resolve site-related operational and/or regulatory issues

Qualifications:

  • A minimum of 5 years experience in clinical operations
  • Knowledge of GCP regulations
  • Excellent communication, organizational, and negotiation skills.
  • Ability to work within a study team 

Competitive salary, bonus and options available.
 
If you meet the above criteria, please send a word version of your resume to LBrantz@Kleinhersh.com. For similar positions, please visit www.kleinhersh.com

For additional information about this job, please contact: lbrantz@kleinhersh.com