Clinical Trial Manager
Core
Operational leadership of clinical research studies for genomics-based transplant patient solutions, ensuring on-time delivery, data quality, and regulatory compliance.
Role type
Senior Clinical Trial Manager
Builds
End-to-end execution of clinical trials (site identification, start-up, conduct, monitoring, closeout) for transplant patient care products.
Domain
Biotechnology / Clinical Research / Organ Transplantation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, site activation and enrollment, risk mitigation, cross-functional leadership, contract review, vendor oversight, data quality assurance, regulatory compliance (ICH/GCP/FDA), project management
Preferred skills
Organ transplantation study experience, clinical research associate experience, on-site/remote clinical monitoring experience
Technologies
eTMF, CTMS, EDC (Medrio, Medidata), Microsoft Office
Responsibilities
Lead end-to-end clinical trial execution including site identification, start-up, conduct, monitoring, and closeout; Drive site activation, enrollment, and overall study performance; Proactively identify study risks and lead mitigation planning; Oversee Clinical Research Associates, CROs, central labs, and external vendors; Ensure data quality and inspection readiness through proactive review; Maintain strong communication with clinical sites and stakeholders; Support study administration activities including site engagement and training
Seniority
Senior, hands-on IC
