Sr. Clinical Study Manager
Core
Lead cross-functional clinical projects to generate evidence for pre-launch and post-launch product registration and claims for immunodiagnostic devices.
Role type
Senior Clinical Project Manager (Immunodiagnostic Devices)
Builds
Clinical evaluation plans, reports, and Trial Master Files for FDA and IVDR submissions
Domain
Medical Devices / In-Vitro Diagnostics / Immunology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design, statistics, medical terminology, project management, risk mitigation, audit preparedness, regulatory compliance (GCP, IVDR, FDA)
Preferred skills
Immunology, auto-immunity, allergy, Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS)
Technologies
Microsoft Office suite
Responsibilities
Develop clinical strategies and plans, ensure studies comply with SOPs/GCP/IVDR/FDA, generate clinical evaluation plans and reports, build Case Report Forms (CRF), support Clinical Research Associates (CRAs) during initiation and close out, identify project risks and implement mitigation plans, report progress to governance boards, provide decision support to management
Seniority
Senior, hands-on IC
