Assistant Clinical Project Manager

Job Locations US-MA-Bedford
Posted Date 6 months ago(3/19/2021 1:38 PM)
Job ID
2021-1425
# of Openings
2
Category
Clinical

Overview

Position Summary:

 

The Assistant Clinical Project Manager provides support to Associate CPMs, CPMs, and Sr. CPMs in executing activities associated with the set-up, management and closure of clinical studies.

Responsibilities

Principal Duties and Responsibilities include the following:

 

  • May assist with the generation of the clinical development plan.
  • Assists with 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.).
  • Performs administrative tasks associated with vendor identification, selection and management activities.
  • Assists with the maintenance of the task ownership matrix to ensure internal and external stakeholders are aligned on assigned responsibilities.
  • Supports study training activities for all study team members and ensures training is documented.
  • Assists with the tracking of study specific decisions, actions, issues and risks information throughout the lifecycle of the study.
  • May attend project team and other cross-functional meetings.
  • May attend quality oversight and site engagement visits.

 

 

Qualifications

Qualification Requirements:

 

Bachelor’s degree in health profession, science and/or engineering field.

A minimum of 5 years of experience in the medical device or pharmaceutical industry, including 4 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

 

  • Working Conditions:

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

 

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