MedTech Clinical Safety Manager
Core
Client-facing manager coordinating medical device and combination product safety projects across clinical and post-market programs, ensuring contractual commitments and regulatory compliance.
Role type
Senior project management IC (clinical safety)
Builds
Safety project deliverables, committee meeting outcomes, and client-facing status reports
Domain
MedTech / Clinical Research / Regulatory Compliance
Required skills
Project coordination, Clinical Events Committee (CEC) management, Data Safety Monitoring Board (DSMB) coordination, Safety documentation management, Client communication, Regulatory compliance tracking, Risk escalation, Cross-functional collaboration, Microsoft Office proficiency, Process improvement
Preferred skills
Medical device clinical trial experience, Safety database/CTMS/eTMF familiarity, Adverse event reporting knowledge, GCP/FDA/ISO 14155/EU MDR knowledge, Billable consulting environment experience
Technologies
Microsoft Office (Excel, Word, PowerPoint, Outlook), Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), Safety databases
Responsibilities
Manage day-to-day execution of client safety projects; Develop and maintain project plans and timelines; Lead and coordinate CEC and DSMB meetings; Collect and maintain safety documentation and adverse event reports; Support case intake and data entry; Prepare project status reports and presentations; Serve as day-to-day contact for assigned projects; Collaborate with Clinical Operations, Regulatory Affairs, and Quality teams; Support inspection and audit readiness; Contribute to safety process refinement; Monitor project performance and recommend improvements.
Seniority
Senior, hands-on IC