Project Manager, Clinical Research

MicroVention Terumo   •  

Aliso Viejo, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 164 days ago

This job is no longer available.

Position Overview

  1. Manages company-sponsored and investigator-sponsored clinical studies in line with institutional, GCP, regulatory, and compliance requirements
  2. Collaborates with study PIs, coordinating centers, CROs, and/or sponsoring institutions to develop protocols, establish budgets, construct databases, select sites, set enrollment targets, and implement enrollment and mitigation plans
  3. Works with legal team to facilitate preparation of clinical trial agreements, physician consulting agreements, and other related contracts
  4. Partners with study site coordinators to prepare IRB submissions and address IRB questions
  5. Prepares/assists in the preparation of study documentation including protocol amendments, Case Report Forms, Informed Consent Forms, and monitoring plans
  6. Facilitates/supports training of and communication with study sites/subsites via regular email/phone contact, study newsletters, and in-person investigator and coordinator meetings
  7. Reports, tracks, and interprets study data, enrollment trends, and other metrics
  8. Ensures appropriate safety/adverse events reporting
  9. Tracks and manages study budgets and expenditures
  10. Provides regular study status reports to management and internal business partners
  11. Reviews publication drafts and fields physician requests for publication support as needed
  12. Leads pilot data collection efforts as needed
  13. Attends study investigator/coordinator meetings, offsite study meetings, and other professional conferences as needed to support study startup and enrollment
  14. Directs Clinical Research Associates, Clinical Research Coordinators, and administrative personnel as needed to support the above activities
  15. Performs other clinical research-related duties as assigned

Job Details

    • Job ID 5531BR
    • Aliso Viejo, California, USA

Apply for this job

    1. Bachelor’s Degree in related field or equivalent experience
    2. Six plus years of direct clinical research experience in the medical device industry
    3. One plus year of management or project management experience
    4. IDE and/or global clinical research experience a plus