Manager, Clinical Study Operations
Core
Lead a team managing end-to-end execution of device-based clinical trials for neurological, psychiatric, and sleep disorder therapeutics.
Role type
Manager, Clinical Study Operations
Builds
Device-based clinical trials for novel therapeutics
Domain
Life Sciences / Clinical Trials / Neurology
Deliverable
production ML models
Required skills
Clinical trial operations management, Team leadership, Risk escalation, Process standardization, Vendor/CRO management, Regulatory compliance (GCP/FDA), Cross-functional collaboration, Asynchronous remote work
Preferred skills
Device-based trial experience, Proprietary CTMS/eTMF tooling, Startup environment adaptability
Technologies
CTMS, eTMF, Qualio, Asana
Responsibilities
Manage direct reports and oversee study execution from feasibility to close-out, Drive domain-level ClinOps initiatives and process improvements, Represent ClinOps in BD and feasibility discussions, Manage relationships with sponsors and CROs, Escalate risks and blockers to leadership, Maintain SOPs and CTMS practices
Seniority
Manager, hands-on leadership