Clinical Operations Senior Project Manager

University of Southern California (USC)

Los Angeles, CA, USA
Base: $107k - $133k annually; bonus/equity: not sp...
Hybrid
Master's degree plus 3 years clinical research experience
Experience managing preclinical translation and clinical studies
Knowledge of ich-gcp guidelines and fda regulations
The role involves managing operations and day-to-day activities for the USC+CHLA Alpha Clinic, a program dedicated to advancing cell and gene therapies

Job Summary

  • The role involves managing operations and day-to-day activities for the USC+CHLA Alpha Clinic, a program dedicated to advancing cell and gene therapies.
  • The successful candidate will develop standard operating procedures, ensure compliance with FDA regulations and ICH-GCP guidelines, and oversee quality control reviews.
  • This position offers an opportunity to engage diverse communities in research and collaborate with a state-wide network of Alpha Clinics supported by the California Institute for Regenerative Medicine.

Matching Summary

The role involves managing operations and day-to-day activities for the USC+CHLA Alpha Clinic, a program dedicated to advancing cell and gene therapies.

Salary

Base: $107K - $133K annually; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Master's degree plus 3 years clinical research experience
  • Experience managing preclinical translation and clinical studies
  • Knowledge of ICH-GCP guidelines and FDA regulations
  • Strong technical documentation and scientific writing skills
  • Ability to supervise staff and manage multi-site teams

Nice-to-have

  • Experience with gene and cell therapy development
  • Data management systems and analytics expertise
  • Regulatory affairs experience including IND modules
  • Diplomacy and relationship cultivation at all levels
  • Proficiency in OmniPlan or timeline applications

Key Requirements

  • Master's degree required
  • Minimum 3 years work experience in clinical research setting
  • Demonstrated experience supervising others
  • Understanding of health sciences research policies
  • Experience in complex medical or academic settings

Work Rights

Not specified

Tailored Resume

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