Senior Manager, Clinical Trials

Responsibilities:
- Own end-to-end planning and execution of a portfolio of complex clinical research projects on a global scale.
- Manage day-to-day clinical study operations, including site relationships, enrollment tracking, protocol deviation resolution, and regulatory compliance.
- Manage study timelines and metrics; oversee adherence.
- Plan/lead study-specific meetings (study team and investigator meetings).
- 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, and approve invoices against budget.
- Participate in vendor selection, qualification, and ongoing oversight planning.
- Oversee CRO/external vendor performance related to site management (monitoring reports, KPIs, and escalation of performance gaps).
- Ensure trials are executed in compliance with international GCP/SOPs; review monitoring reports and support site issue resolution.
- Coordinate regulatory/ethics committee activities as appropriate.
- Serve as primary site contact for investigators (device protocol training, monitoring visits, resolve data queries).
- Support quality assurance: resolve audit findings and CAPAs; ensure audit-ready trial documentation including TMF.
- Ensure trials follow international/local mandates (e.g., FDA, ICG-GCP, ISO 14155).
- Maintain integrated timelines; flag risks/delays to the Clinical Development Lead.
- Develop operating budgets; track expenses; negotiate site/vendor contracts; mitigate financial/operational variances.
- Develop trial documents and support IRB submissions; maintain study/site issue and protocol deviation logs.

Qualifications:
- Bachelor’s degree required (life sciences or nursing preferred).
- Minimum 8 years clinical research execution in medical devices.
- End-to-end medical device clinical trial leadership experience (feasibility through inspection readiness).
- Understanding of regulatory authority requirements for clinical study report submissions.
- Experience overseeing CROs/vendors/partners (selection, budget oversight, metrics, escalation, invoice review).
- Ability to manage in-house and external CRO site models.
- Ability to manage/oversee clinical sites (startup, activation, enrollment support, ongoing performance).
- Risk management, issue resolution, CAPA support, audit readiness, and inspection preparedness.
- Strong organizational, communication, analytical, and cross-functional collaboration skills; MS Office; experience with EDC and CTMS.
- Minimal travel (~25%).

Preferred Qualifications:
- Experience in medical aesthetics energy-based devices; KOL/investigator community relationships.
- Certifications: CCRP or ACRP-CP.
- Global clinical trial management experience.
- Deep GCP/regulatory knowledge (ISO 14155, ICH, and medical device directives).

Benefits:
- Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short- and long-term disability, life and AD&D, paid holidays, employee referral bonuses, and employee discounts.