Clinical Project Manager

Job Locations US-MA-Bedford
Posted Date 4 months ago(3/19/2021 1:37 PM)
Job ID
2021-1427
# of Openings
3
Category
Clinical

Overview

Position Summary:

 

The Clinical Project Manager executes 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 and within budget. 

Responsibilities

Principal Duties and Responsibilities include the following:

 

  • Contributes to the clinical development plan. 
  • Oversees the execution of assigned studies from conception through study closure and final inspection preparation.
  • Participates in the development and review of study documents (i.e. protocol, ICF template, plans, manuals, site recruitment materials, CSRs, etc.).
  • Executes vendor identification, selection and management activities in collaboration with department leadership. 
  • Collaborates with internal and external stakeholders to ensure alignment of responsibilities. 
  • Develops and maintains study timelines, budget and ensure study is appropriately resourced. 
  • Ensure study training is provided and documented for all study team members. 
  • May represent clinical operations at project team and other cross-functional meetings. 
  • Ensures study specific decisions, actions, issues and risks information is documented throughout the lifecycle of the study. 
  • May conduct quality oversight and site engagement visits.

 

Position may supervise Clinical Research Associates and Clinical Trial Associates.

 

 

Qualifications

Qualification Requirements:

 

Bachelor’s degree in health profession, science and/or engineering 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, Excel, PowerPoint, etc.

Excellent organizational skills and attention to detail.

Ability to apply knowledge of GCP and applicable regulations and guidances appropriately

 

Some travel would be required for educational seminars, study oversight and site engagement visits. Ability to travel approximately 35%.

 

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