Clinical Project Manager - Boston, United States - Cardiovascular Clinical Studies

Cardiovascular Clinical Studies
Cardiovascular Clinical Studies
Verified Company
Boston, United States

1 week ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter


Description

Job Summary

Clinical Project Manager - Hybrid In Office Position

  • Manage all aspects of multicenter Phase I-IV clinical trials
  • Oversight and supervision of clinical operational trial team
  • Oversee study materials development and distribution, investigator meeting planning
  • Manage study startup and clinical site management escalation plan implementation
  • Manage central IRB submissions, and communications
  • Regulatory document collection oversight and internal approval (signoff)
  • Prepare Monthly Trial newsletters
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Record, prepare and distribute meeting agendas and meeting minutes for team calls:

  • Executive Committee Management (set up, charter drafting, coordination of meetings, meeting minutes, master files, etc)
  • Oversight of vendors e.g. clinical and specialty labs, technical vendors, core labs
  • Provide clinical assistance to sites, monitors, sponsor and other trial team members
  • Other special projects as assigned by Senior Management including regulatory, safety or quality control oversight for a particular project or projects
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Skills / Requirements:


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

Work Experience

  • 7+ years of clinical trial experience
-
3+ years of Project Manager Experience Required

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.

Pay:
$91, $121,190.00 per year


Benefits:


  • 401(k)
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Monday to Friday

Application Question(s):

  • How many years experience do you have working in Clinical Research either at a CRO or Site?
  • This is NOT a remote position, Will you be able to come into the office 5 days a week located in Boston, MA

Experience:


  • Project management in
Clinical Research: 2 years (preferred)


Work Location:
In person

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