Senior Manager, Clinical Trials

Responsibilities Own end-to-end planning and execution of a portfolio of complex global clinical research projects. Manage day-to-day clinical study operations: site relationships, enrollment tracking, protocol deviation resolution, and regulatory compliance. Manage study timelines and metrics; ensure adherence. Plan/lead study-specific meetings (study team, investigator). Own operational components such as CRF design and TMF management. Partner cross-functionally (Clinical, Regulatory, Data Management, Quality, Medical Affairs) to ensure alignment and study success. Oversee third-party vendors: review reports/budgets/metrics; review and approve vendor invoices. Participate in vendor selection/qualification and ongoing oversight. Oversee CRO/external vendor performance for site management; review monitoring reports, track KPIs, and elevate performance gaps. Ensure trials are executed in compliance with international GCP guidelines/SOPs and applicable mandates (e.g., FDA, ICH-GCP, ISO 14155). Review monitoring visit reports; assist with site monitoring as appropriate. Coordinate support for regulatory/ethics committee activities. Serve as primary site contact for investigators: provide device protocol training, conduct monitoring, resolve data queries. Support QA/audits: resolve findings and CAPAs; ensure audit-ready trial documentation including TMF. Maintain integrated study timelines; flag risks/delays to Clinical Development Lead. Develop operating budgets; track expenses; negotiate contracts; mitigate financial/operational variances. Develop clinical trial documents and support IRB submissions; maintain shared logs (e.g., Study/Site Issue Log, Protocol Deviation Log). Ensure trials complete on schedule and within budget (initiation through close-out). Qualifications Bachelor’s degree required (life sciences or nursing preferred). 8+ years of clinical research execution in the medical device industry. End-to-end medical device trial experience (feasibility, startup, enrollment, monitoring, close-out, inspection readiness). Understanding of regulatory authority requirements for clinical study report submissions. Experience overseeing CROs/vendors/external partners (selection, budget oversight, performance metrics, escalation, invoice review). Ability to manage in-house and external CRO site models and clinical sites (startup/activation, enrollment support, performance). Strong risk management, issue resolution, CAPA support, audit readiness, and inspection preparedness. Excellent organizational, communication, interpersonal, analytical, and cross-functional skills. Proficiency with MS Office; experience with EDC systems and CTMS. Minimal travel (~25%). Preferred Qualifications Medical aesthetics energy-based device industry experience. KOL networks/investigator community relationships in aesthetics. Certifications (CCRP or ACRP-CP). Global clinical trial management experience. Deep GCP/regulatory knowledge (ISO 14155, ICH, and device regulations). Benefits (if applicable per posting) Medical (includes prescription drug), dental, vision; Flexible Spending Accounts; 401(k) with matching; discretionary time off and paid sick time; stock purchase plan; tuition reimbursement; parental leave; short- and long-term disability; life and AD&D insurance; paid holidays; referral bonuses; employee discounts. #J-18808-Ljbffr