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 regulatory-compliant study documentation for peripheral intervention devices.
Domain
Medical Technology / Clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical safety management, GCP knowledge, clinical study processes, safety event monitoring, regulatory compliance, data query resolution, audit preparation, stakeholder communication, document development, issue escalation, vendor management.
Preferred skills
Peripheral vascular disease experience, end-stage kidney disease experience, oncology 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 reportable safety events and trends; develop and manage study-specific Clinical Safety Plans and related documentation; perform TMF audits; facilitate communication between clinical sites and stakeholders; manage safety-related interactions and invoicing for Medical Monitors and vendors; support internal/external audits; mentor Clinical Safety personnel.
Seniority
Mid-level, hands-on IC
