Clinical Study Operations Manager
Core
Ensuring successful operational delivery of clinical studies from startup through close-out for neurological, psychiatric, and sleep disorder therapeutics.
Role type
Senior IC Clinical Study Operations Manager
Builds
Clinical studies for novel therapeutics and precision diagnostics
Domain
Life Sciences / Clinical Research / Neurology
Deliverable
client delivery
Required skills
Clinical project management, GCP compliance, site onboarding and training, regulatory standards adherence, risk identification, stakeholder communication
Preferred skills
Decentralized data collection oversight, analytics/statistics/ML familiarity, device workflow optimization
Technologies
Zendesk, Asana
Responsibilities
Oversee study startup planning, site onboarding, and operational oversight; Act as primary point of contact for clinical sites; Provide training to research sites on device usage and protocols; Monitor project progress and adherence to timelines/protocols; Coach peers on GCP compliance and documentation discipline; Address operational issues and escalate via tools; Provide feedback to inform device and workflow improvements.
