Clinical Site Manager
Core
Manage clinical trial sites and monitor data collection for cardiovascular medical device studies, ensuring compliance with protocols and regulations.
Role type
Senior Clinical Site Manager (Medical Devices)
Builds
Clinical trial data integrity and regulatory compliance for heart recovery, electrophysiology, and stroke solutions.
Domain
Healthcare / Medical Devices / Cardiovascular
Deliverable
client delivery
Required skills
Clinical trial monitoring, GCP compliance, site management, data documentation review, regulatory documentation, protocol adherence, site training, CRA mentorship, travel management
Preferred skills
Master's degree in science, ACRP/SoCRA certification, experience with Class II/III medical devices, experience with Veeva Vault CTMS/eTMF and Medidata/Rave EDC
Technologies
Veeva Vault CTMS, eTMF, Medidata Rave, MS Office Suite
Responsibilities
Serve as Subject Matter Expert for monitoring and site management activities; review study level trends and monitoring visit reports; facilitate meetings between project stakeholders; provide strategic direction on field monitoring and data collection; lead development of technical training on GCPs and protocols; resolve complex data and regulatory discrepancies; develop and mentor Clinical Research Associates; support site start-up, initiation, monitoring, and close-out visits; participate in audit of clinical trials.
Seniority
Senior, hands-on IC with mentorship responsibilities
