1-617-500-6690 [email protected]
  • Full Time (Salaried)
  • Remote,

Company:  Confidential

Job Title: Clinical Project Manager

Job Number: 32001

Location: Remote, 

Job Description

The Clinical Project Manager (Clinical PM) plays a key role in the successful conduct of a clinical trial from inception through implementation and completion.  The Clinical PM provides overall coordination and strategic management of a clinical trial, in conjunction with the clinical team and other functional groups. The Clinical Project Manager serves as the primary contact with the sponsor, clinical team, and other functional groups, while effectively delegating, and overseeing team members.

The Clinical Project Manager ensures that all study team members are appropriately trained on the study and maintain compliance with GCP, the protocol, other associated documents, scope of work, and other clinical objectives. The Clinical PM serves as an effective team leader who manages and motivates team members using positive and productive methods of communication. The Clinical Project Manager also supports team member mentorship, as needed.

Responsibilities

  • Lead all clinical study operations, providing strategic/tactical planning, organization, and direction of study project(s) including but not limited to the oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data collection
  • Facilitate and foster positive, productive, and timely communication between Sponsor, study team, and other functional groups
  • Manage and motivate study team while serving as a mentor.  Mentorship may include identifying skills of the clinical team members and assisting with further professional development
  • Provide proper financial oversight of study budget, including out of scope tracking, in conjunction with the Client Manager (CM) and ProTrials Finance Department
  • Collaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals (Project Review)
  • Drive the development, maintenance, and distribution of project plans based on project-specific requirements, throughout the life of the study (i.e. monitoring plan, communication plan, project management plan, eTMF plan, other plans as applicable)
  • Manage studies in compliance with GCP, relevant SOPs, regulatory requirements, and project-specific plans
  • Assess resourcing needs to ensure the study has the appropriate resources for the duration of the project
  • Actively manage and track study risks (with team and Sponsor input for potential obstacles that would delay the project’s progress while appropriately escalating issues
  • Assess training needs of team members on the therapeutic area, protocol, special procedures/skills, and implement the appropriate training plans
  • Delegate study team responsibilities and ensure that team members have the necessary tools and resources to effectively perform their role
  • Monitor and manage the project’s progress and develop timelines with input from relevant stakeholders and sponsor approval; re-assess critical path for study progress and adjust timelines as needed
  • Oversee activities and deliverables of outside vendors, as requested; ensure communication occurs between outside vendors, the team, and sponsor

Required Skills

  • RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and previous CRA experience

 

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