Clinical Safety Specialist
Core
Deliver high-quality and compliant Clinical Safety management for clinical studies (EFS/FIH, IDE, Post-Market) sponsored by the BD Peripheral Intervention business unit to ensure scientific quality, integrity, and ethics.
Role type
Clinical Safety Specialist (Medical Device)
Builds
Clinical safety deliverables, tracking reports, and study documents for peripheral intervention devices.
Domain
Medical Technology / Clinical Research
Required skills
Clinical safety management, GCP knowledge, clinical study processes, safety event monitoring, regulatory compliance, audit management, stakeholder communication, document development, trend analysis, issue escalation
Preferred skills
Peripheral vascular disease experience, medical device study experience, Veeva Vault proficiency, professional certification (ACRP/SOCRA)
Technologies
Microsoft Suite, eTMF, CTMS, CDMS, Veeva Vault
Responsibilities
Monitor assigned clinical studies for safety events and trends, develop and manage Clinical Safety Plans and related study documents, conduct TMF audits, report and escalate product complaints, manage interactions with Medical Monitors and vendors, support internal/external audits, mentor Clinical Safety personnel.
Seniority
Mid-level, hands-on IC