Associate Clinical Project Manager

Job Locations US-MA-Bedford
Posted Date 4 weeks ago(7/14/2020 1:44 PM)
Job ID
2020-1328
# of Openings
1
Category
Clinical

Overview

The Associate Clinical Project Manager assists with the execution of 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

1. Assists with the generation of the clinical development plan.

2. Coordinates the execution of assigned studies from conception through study closure and final inspection preparation.

3. Participates in the development and review of study documents (i.e. protocol, ICF template, plans, manuals, site recruitment materials, CSRs, etc.).

4. Assists with vendor identification, selection and management activities in collaboration with department leadership.

5. Maintains task ownership matrix to ensure internal and external stakeholders are aligned on assigned responsibilities.

6. Assists with the development and maintenance of study timelines and budget; also ensures study is appropriately resourced.

7. Provides study training for all study team members and ensures training is documented.

8. Documents study specific decisions, actions, issues and risks information throughout the lifecycle of the study.

9. May represent clinical operations at project team and other cross-functional meetings.

10. May conduct quality oversight and site engagement visits.

Qualifications

  • Position may supervise Assistant Clinical Project Managers and Clinical Trial Associates.
  • Bachelor’s degree in health profession, science and/or engineering field.
  • A minimum of 7 years of experience in the medical device or pharmaceutical industry, including 5 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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