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Senior Clinical Trial Manager


This job is no longer available.

Company Overview: 

 Meet is currently working with a company who is seeking a Clinical Trial Manager/Sr Clinical Trial Manager to join the Clinical Development Team. As a member of our team, you’ll work closely with internal team members and vendors as well as clinical study sites ensuring that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and budgets. You’ll have responsibility for managing the operational aspects of clinical trials including managing clinical operations personnel.

Job Description: 

  • Managing the operational aspects of clinical trials
  • Managing Clinical Operations personnel
  •  Managing the study project plan, including timeline, budget and resources
  • Participates in protocol, CRF and strategy development, Clinical Study Report preparation, and NDA submission'
  • Preparing metrics and updates
  • Proactively identifying potential study issues/risks and recommending/implementing solutions 

CRO/vendor activities including:

  • Participating in and facilitating the CRO/vendor selection process for outsourced activities
  • Managing CRO interactions including sponsor oversight of operational functional activities (study management, monitoring, site management, project master files)
  • Working with the CRO to develop and revise scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations are met
  • Preparing, reviewing, and approving study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual and CRF Completions Guidelines)
  • Managing clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Participating in the development, review and implementation of departmental SOPs and processes
  • Recommending and implementing innovative process ideas to positively impact clinical trials management
  • Organizing and managing internal team meetings, investigator meetings and other trial-specific meetings; serving as a liaison and resource for investigational sites
  • Reviewing site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
  • Participating in the selection, training and evaluation of study personnel (contract and internal) to insure the efficient operation of the function
  • Serving as a liaison and resource for investigational sites
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