Senior Manager, Clinical Trials
Bausch Health Companies Inc.
September 02, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Responsibilities:
- Own end-to-end planning and execution of a global portfolio of complex clinical research projects (feasibility through close-out).
- Manage day-to-day clinical study operations: site relationships, enrollment tracking, protocol deviations, and regulatory compliance.
- Maintain study timelines/metrics; run study-specific meetings.
- Own operational components (e.g., CRF design, TMF management).
- Oversee third-party vendors: review reports/budgets/metrics; approve invoices; participate in vendor selection/qualification; oversee CRO/vendor performance and escalate gaps.
- Ensure GCP/SOP compliance and adherence to FDA/ICG-GCP/ISO 14155; review monitoring reports; support regulatory/ethics activities.
- Serve as primary site contact: device protocol training, monitoring visits, resolve data queries.
- Support quality/audits: resolve audit findings and CAPAs; maintain audit-ready TMF.
- Maintain integrated timelines; develop budgets; negotiate site/vendor contracts; develop trial documents and support IRB submissions; maintain logs (e.g., deviation/issue logs).
Qualifications (Required):
- Bachelor’s degree (life sciences or nursing preferred).
- 8+ years clinical research execution in medical devices.
- End-to-end device trial execution experience (feasibility/start-up/enrollment/monitoring/close-out/inspection readiness).
- Understanding of regulatory requirements for clinical study report submissions.
- Experience overseeing CROs/vendors/partners (selection, budget, performance metrics, escalation, invoice review).
- Ability to manage in-house and external CRO site models.
- Ability to manage clinical sites (startup/activation/enrollment support/performance).
- Strong risk management, issue resolution, CAPA support, audit readiness.
- Strong communication, organization, cross-functional collaboration; MS Office; EDC and CTMS experience.
Preferred:
- Medical aesthetics energy-based device experience; KOL/investigator relationships.
- CCRP or ACRP-CP.
- Global clinical trial management.
- Deep GCP/regulatory knowledge (ISO 14155, ICH, device directives).
Benefits:
- Medical (includes prescription drug), dental, vision; Flexible Spending Accounts; 401(k) match; 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; employee referral bonuses and discounts.
- Own end-to-end planning and execution of a global portfolio of complex clinical research projects (feasibility through close-out).
- Manage day-to-day clinical study operations: site relationships, enrollment tracking, protocol deviations, and regulatory compliance.
- Maintain study timelines/metrics; run study-specific meetings.
- Own operational components (e.g., CRF design, TMF management).
- Oversee third-party vendors: review reports/budgets/metrics; approve invoices; participate in vendor selection/qualification; oversee CRO/vendor performance and escalate gaps.
- Ensure GCP/SOP compliance and adherence to FDA/ICG-GCP/ISO 14155; review monitoring reports; support regulatory/ethics activities.
- Serve as primary site contact: device protocol training, monitoring visits, resolve data queries.
- Support quality/audits: resolve audit findings and CAPAs; maintain audit-ready TMF.
- Maintain integrated timelines; develop budgets; negotiate site/vendor contracts; develop trial documents and support IRB submissions; maintain logs (e.g., deviation/issue logs).
Qualifications (Required):
- Bachelor’s degree (life sciences or nursing preferred).
- 8+ years clinical research execution in medical devices.
- End-to-end device trial execution experience (feasibility/start-up/enrollment/monitoring/close-out/inspection readiness).
- Understanding of regulatory requirements for clinical study report submissions.
- Experience overseeing CROs/vendors/partners (selection, budget, performance metrics, escalation, invoice review).
- Ability to manage in-house and external CRO site models.
- Ability to manage clinical sites (startup/activation/enrollment support/performance).
- Strong risk management, issue resolution, CAPA support, audit readiness.
- Strong communication, organization, cross-functional collaboration; MS Office; EDC and CTMS experience.
Preferred:
- Medical aesthetics energy-based device experience; KOL/investigator relationships.
- CCRP or ACRP-CP.
- Global clinical trial management.
- Deep GCP/regulatory knowledge (ISO 14155, ICH, device directives).
Benefits:
- Medical (includes prescription drug), dental, vision; Flexible Spending Accounts; 401(k) match; 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; employee referral bonuses and discounts.