CLINICAL TRIAL MANAGER
Core
Operational planning, execution, and oversight of clinical trials for allogeneic gamma delta T cell therapies targeting autoimmune diseases and cancer.
Role type
Senior Clinical Trial Manager
Builds
Global clinical studies for CAR-T cell therapy pipeline
Domain
Biotechnology / Oncology / Autoimmune diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, GCP/ICH compliance, CRO/vendor oversight, site activation and monitoring, TMF management, enrollment tracking, risk mitigation, IRB preparation, electronic data capture systems, project management
Preferred skills
Molecular diagnostics knowledge, laboratory skills
Responsibilities
Lead site and study management activities including ICFs, activations, and monitoring reports; Collaborate cross-functionally to address study issues; Manage CRO and vendor relationships to ensure milestones; Perform co-monitoring visits for site qualification, initiation, routine monitoring, and close-out; Generate and maintain reports, listings, and trackers; Track site enrollment metrics; Establish and manage clinical trial master files (TMF)
Seniority
Senior, hands-on IC