Clinical Operations Manager
Core
Planning, execution, and oversight of clinical studies for an in vitro diagnostics platform to support FDA clearance.
Role type
Senior Clinical Operations Manager
Builds
Pivotal multi-site clinical studies for diagnostic/medical device platform
Domain
Healthcare / In vitro diagnostics / Clinical trials
Required skills
Clinical study start-up and execution, IRB submissions and regulatory coordination, Site selection and qualification, Site monitoring (on-site and/or remote), GCP and ICH guidelines compliance, Vendor and CRO management, Protocol development support
Preferred skills
Building clinical trial infrastructure at early-stage companies, Managing diagnostic/medical device clinical trials
Technologies
Clinical trial management systems, Regulatory documentation tools
Responsibilities
Lead clinical study start-up and execution for pivotal multi-site studies, Own IRB submissions and regulatory coordination, Manage site selection, qualification, initiation, and monitoring, Serve as primary operational point-of-contact for clinical sites and reference laboratories, Develop and maintain core clinical documentation to ensure GCP compliance, Track site status, operational milestones, and key deliverables, Coordinate external clinical vendors and support contracting and budget communications, Support development of protocol and preparation of regulatory-facing study materials