Senior Manager, Trial Operations
Core
Strategic and hands-on leadership for Phase 3 clinical trials, overseeing execution from study start-up through closeout to ensure high-quality delivery against plan.
Role type
Senior Manager, Trial Operations
Builds
Phase 3 clinical trials for neuroscience therapeutics (epilepsy, depression, pain)
Domain
Biopharmaceuticals / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Phase 3 trial operations oversight, cross-functional team leadership, vendor/CRO management, study budget and timeline management, risk assessment and mitigation, regulatory compliance (ICH/GCP), protocol and regulatory document development
Preferred skills
Experience with CTA and IND submissions, knowledge of US and Canadian regulatory environments
Technologies
Clinical trial management systems, regulatory submission platforms
Responsibilities
Lead preparation and evaluation of RFPs for CRO selection; manage contracted service providers to deliver against contracts; select qualified investigators and study sites; review and oversee study budgets and invoices; develop and manage study timelines and metrics; conduct risk assessments and contingency planning; participate in the development and finalization of clinical trial protocols, consent forms, and case report forms; train and mentor new staff; oversee adherence to regulations and clinical trial protocols.
Seniority
Senior Manager, hands-on IC with strategic oversight
