Clinical Manager, Safety and Compliance

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Clinical Manager, Safety and Compliance

SetPoint Medical's Clinical Manager of Safety and Compliance leads safety oversight, regulatory compliance, and quality assurance across the company's active clinical study portfolio. This role is instrumental in ensuring that every study is conducted in accordance with the protocol, company SOPs, ICH-GCP, ISO 14155, and applicable FDA and EU MDR requirements. This position owns safety reporting, proactively identifies and mitigates study risks, keeps Clinical inspection-ready, and champions a culture of continuous quality improvement as the study portfolio grows.

In a fast-paced start-up environment, this role will need effective communication skills, the ability to excel under pressure, the ability to follow a task from start to finish, and excellent cross-functional team collaboration.

• Serve as the primary owner of adverse event (AE), serious adverse event (SAE), and device deficiency intake, triage, and documentation across all active studies, ensuring consistent application of company safety reporting procedures and regulatory timelines.
• Review and assess causality, severity, expectedness, and reportability determinations in collaboration with the Medical Monitor/Safety Physician, including identification of unanticipated adverse device effects (UADEs); elevate potential safety signals promptly and appropriately.
• Ensure ongoing reconciliation of safety data across site source documents, EDC, and the safety database, and coordinate safety data flow to Clinical Events Committees (CECs) and DSMBs/DMCs.
• Support the compilation of safety data for clinical study reports, DSMB/DMC packages, and regulatory submissions (e.g., IDE supplements, PMAs, and 510(k) s, as applicable).

• Develop and execute an annual risk-based compliance audit and monitoring plan covering active studies, investigational sites, CROs, and other clinical vendors.
• Plan and conduct routine, for-cause, and pre-inspection audits evaluating informed consent, subject eligibility, protocol adherence, investigational device accountability, source documentation, and Trial Master File (TMF) completeness; issue clear, objective audit reports and track corrective and preventive actions (CAPAs) through closure.
• Oversee adherence to study protocols and monitoring plans to ensure site compliance, data integrity, and subject safety across all studies.
• Monitor protocol deviations across studies, ensure root-cause analysis and CAPA implementation, and maintain deviation logs and trending reports for management review.
• Investigate suspected serious or continuing noncompliance at investigational sites, recommend escalation actions (e.g., corrective action plans, enrollment holds, site closure) consistent with sponsor obligations under 21 CFR 812.46, and support required reporting to FDA and IRBs.

• Lead inspection readiness activities and coordinate company and site preparation for FDA Bioresearch Monitoring (BIMO) inspections, IRB audits, and notified body audits; draft or review responses to inspection observations (e.g., FDA Form 483).
• Ensure compliance with investigator financial disclosure requirements (21 CFR Part 54) and electronic records and signatures requirements (21 CFR Part 11) for clinical systems.
• Monitor changes in regulations, standards, and guidance (e.g., FDA, EU MDR, ISO 14155, ICH E6) and assess their impact on company SOPs and study conduct.

• Develop, maintain, and continuously improve SOPs, work instructions, and training materials related to safety reporting, GCP compliance, and study conduct.
• Design and deliver training for internal clinical staff, CRAs, and site personnel on GCP, safety reporting, informed consent, documentation practices, and lessons learned from audits and inspections.
• Lead or support process-improvement initiatives that strengthen the consistency and efficiency of compliance practices as the study portfolio grows.
• Maintain current professional and technical knowledge through educational workshops, professional publications, industry networks, and participation in professional societies.

• Partner with Clinical Operations, Regulatory Affairs, Quality, and Medical Safety to identify risk trends and drive continuous improvement in a fast-paced environment.
• Track and report…