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Clinical Project Manager

  • Job type: Contract
  • Location: Boston, Massachusetts
  • Salary: Competitive
  • Job reference: 286821/001_1552433690
  • Sector: Clinical Operartions, EPM Scientific
  • Date posted: 12/03/2019

Clinical Project Manager

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

  • Manage multi-center Phase I-IV clinical trials by site identification, protocol review with investigative sites, prequalification, initiation, clinical site management and study closeout.

  • Oversight and supervision of clinical trial team including, Sr. Clinical Project Coordinators, Clinical Project Coordinators, and Clinical Trial Assistants

  • 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

  • Regulatory document collection oversight and internal approval (sign-off)

  • Prepare Monthly Trial newsletters

  • 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)

  • Contribute to 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

  • Provide clinical assistance to sites, monitors, sponsor and other trial team members through a clinical helpline pager.

  • Manage Medical Monitor documentation - recording calls on log, preparation of waivers and recording waivers in a waiver log

  • 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 project 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.

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