Site Operations Manager- Contractor
Core
Lead multifunctional study management teams to plan, execute, and close-out clinical studies on-time and on-budget while ensuring compliance with GCP/ICH guidelines and FDA regulations.
Role type
Senior IC clinical study operations manager
Builds
Clinical studies for pharmaceutical/biotech sponsors
Domain
Life Sciences / Clinical Research
Required skills
Clinical study management, multi-disciplinary team leadership, budget and financial management, risk analysis, stakeholder communication, resource planning, regulatory compliance (GCP/ICH/FDA)
Preferred skills
Medical/scientific knowledge, drug development process expertise, experience with decentralized/remote trials
Technologies
MS Office, Google applications, proprietary project management software
Responsibilities
Develop project management plans and milestones, lead multi-disciplinary study teams, monitor study metrics and timelines, act as primary point of contact for sponsor teams, manage study budgets and financial records, coordinate resource assignment, support audit preparations, train study teams on processes
Seniority
Mid-level, hands-on IC