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 escalate 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.