The main responsibility of this position is to facilitate and support the activity of clinical trial committees-Clinical Events Committee (IPAs or ISOCs) and Data Safety Committees, to oversee the handling of Adverse Events/Serious Adverse Events and provide for MedDRA coding if contracted. In addition, the Safety Manager will provide support, direction and mentoring to the Safety Department Medical Reviewers/CEC/ISOC/DMC Liaisons.

Safety Manager should be able and can be asked to perform Medical Reviewer level I/II activities.

Duties and responsibilities will include:

  • Serve as the Lead Medical Reviewer on project teams and provide updates to Project Managers, clients and project team personnel.
  • In collaboration with the Department Manager, Project Manager and/or Medical Director, draft CEC Manual of Operations (MOP) and related documents for assigned trials.
  • Line management for all levels of Medical Reviewers and Safety Associates
  • Coach, train, and support direct reports. This person will manage a team of people that includes 3 Medical Reviewers, 1 Medical Monitor, and 2 Safety Associates.

This person will also manage and distribute workload throughout the team, help direct the flow of projects and help give structure to the department.

Education and Experience:

  • B.A./B.S.in nursing or a related medical/healthcare degree or equivalent experience is preferred.
  • A Registered Nurse with a strong clinical background or equivalent experience.
  • Minimum 3-7 years of experience in personnel management within a clinical research environment preferred.
  • Prior budget development and management experience is preferred.
  • Previous experience with medical device or medical technology studies strongly preferred.