Clinical Trial Manager
Core
Manage clinical monitoring operations, oversee CRA teams, and ensure quality/timeliness of data and deliverables for clinical trials.
Role type
Senior Clinical Trial Manager (Clinical Monitoring)
Builds
Clinical trial monitoring deliverables, data quality, and site management for drug/device development.
Domain
Clinical Research / Biopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Trial Management (CTM), Clinical Research Associate (CRA) management, ICH/GCP compliance, risk planning, study budget oversight, eDC/eTMF/CTMS proficiency, complex medical terminology understanding, mentorship
Preferred skills
Bid defense planning, site initiation visit leadership, cross-functional relationship building
Technologies
CTMS, eTMF, EDC, Microsoft Excel/PowerPoint/Word
Responsibilities
Plan and implement clinical monitoring aspects; coordinate and oversee daily operations of Clinical Monitoring team including CRAs; oversee quality and timeliness of clinical data in eDC; manage project milestones and address deficiencies; mentor CRAs and provide performance feedback; conduct on-site or remote monitoring activities as needed.
Seniority
Senior, hands-on IC with mentorship responsibilities