Clinical Trial Manager

Our Boston- based client is a leading clinical trials research organization with scientific leadership in translational and clinical studies using cardiovascular imaging in fields are looking to add a key management role to their team

Responsibilities of the Clinical Trial Manager include but are not limited to:

  • Manage multi-center Phase I-IV or Pivotal as applicable clinical trials by site identification, protocol review with investigative sites, prequalification, initiation, clinical site management and study closeout. 
  • Oversight of clinical trial team including, Sr. Clinical Project Coordinators, Clinical Project Coordinators, and Clinical Trial Assistants (as applicable)
  • Oversee study materials development and distribution, investigator meeting planning.
  • Manage study start-up and clinical site management – escalation plan implementation.
  • Manage central IRB submissions, and communications
  • Reporting on Trial Timelines to Project Lead(s)
  • Regulatory document collection oversight and internal approval (sign-off)
  • Prepare or contribute to trial newsletters and communications
  • Record, prepare and distribute meeting agendas and meeting minutes for team calls.
  • Contribute to data review for governance calls with sponsor
  • Contribute to authoring and review of project specific plans
  • Contribute to review of statistical analysis plan, annual report, safety report and clinical study report review.
  • Oversight of vendors e.g. clinical and specialty labs, technical vendors, core labs as applicable.
  • Provide clinical assistance to sites, monitors, sponsor and other trial team members.
  • Manage Medical Monitor documentation as applicable
  • Other special projects as assigned by Senior Management including regulatory, safety or quality control oversight for a particular project or projects.

Skills / Requirements:

  • Knowledge of FDA/GCP regulatory requirements
  • Effective communication between site staff, sponsor, internal staff members
  • Knowledge of Microsoft Office applications
  • Ability to work on multiple activities concurrently
  • Attention to detail and process

Work Experience:

  • 7+ years of clinical trial experience
  • 3+ years of trial management experience

Education / Background:

  • B.A. or B.S. degree in scientific field or equivalent
  • Background in nursing in the cardiovascular therapeutic area or other clinical field is preferred. 

If interested, please email Earl Callender


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