Clinical Project Manager - REMOTE

Job Locations US-MA-Bedford
Posted Date 2 months ago(8/9/2022 4:08 PM)
Job ID
2022-1608
# of Openings
1
Category
Clinical

Overview

The Clinical Project Manager (CPM) executes and/or oversees the coordination of activities associated with the set-up, management and closure of clinical studies and is responsible for the successful completion of studies on schedule, within budget and with high quality standards. 

Responsibilities

  • The scope of study responsibilities includes effectively coordinating the activities of the clinical trial team and manage project information and communications to all stakeholders through the lifecycle of drug development
  • Manage and/or oversee the execution of assigned studies
  • Collaborates with internal and external stakeholders to ensure alignment of responsibilities.
  • Manage the development and review of study documents (i.e., IB, Protocol, ICF, plans, manuals, site recruitment materials, CSRs, etc.)
  • Overall responsibility for the TMF
  • Executes vendor identification, selection, and management activities
  • Contribute to clinical Program Team meetings with internal stakeholders to establish effective information sharing and collaboration
  • Main point of contact for CROs and vendors and lead CRO/vendor meetings for assigned studies
  • Oversee and manage study timelines / budgets / contracts and report/escalate issues as needed
  • Ensure study training is planned, provided, and documented for all study team members
  • Ensures study specific decisions, actions, issues and risks are identified and documented throughout the lifecycle of the study and reviewed on a regular basis. Escalate as appropriate
  • Oversee use of systems to track and monitor clinical program objectives/goals
  • Manage inspection readiness activities
  • Perform other duties as required
  • May conduct quality oversight engagement visits. Responsible to foster site relationships

 

Qualifications

  • Bachelor’s degree in health profession or science field
  • A minimum of 8 years of experience in the medical device or pharmaceutical industry, including 6 years of relevant clinical research experience
  • Some monitoring experience is preferred
  • Previous experience leading a clinical study preferred
  • Excellent written and oral communication skills
  • Computer literacy, proficiency in MS Office suite, TEAMS, SharePoint etc.
  • Excellent organizational skills and attention to detail
  • Ability to work virtually
  • Ability to apply knowledge of GCP and applicable regulations and guidance’s appropriately

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