Senior Manager, Clinical Operations (FSP )
Core
Oversee, train, resource, and performance manage a team of clinical operations staff to ensure adherence to SOPs and WPDs while meeting program KPIs.
Role type
Senior Manager, Clinical Operations
Builds
Clinical trial operations and project delivery for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Staff management and coaching, performance appraisal, recruitment, training delivery, risk-based monitoring, quality assurance audits, system evaluation (CTMS, Preclarus), workflow allocation, regulatory compliance (ICH/GCP, FDA)
Preferred skills
Bachelor Degree in Life Science, experience managing CRAs/CTCs/Project Support Coordinators, experience managing FSP clients as Single Point of Contact, process improvement, strategic planning
Technologies
Activate, CTMS, Preclarus, Clarity
Responsibilities
Manage staff including coaching, mentorship, and performance appraisals; Conduct induction programs and maintain employee records; Support project leads in operational optimization; Deliver training on SOPs and WPDs; Ensure adherence to ethical and regulatory standards; Handle system reviews for metrics and KPIs; Collaborate with senior management on strategic planning and business development.
Seniority
Senior, hands-on IC with team leadership
