Senior Manager, Clinical Trials
Bausch Health Companies Inc.
August 21, 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.
- Manage day-to-day clinical study operations: site relationships, enrollment tracking, protocol deviations, and regulatory compliance.
- Maintain study timelines/metrics; lead study-specific meetings.
- Own operational components including CRF design and TMF management.
- Partner cross-functionally (Clinical, Regulatory, Data Management, Quality, Medical Affairs) to ensure study success.
- Oversee third-party vendors: review budgets/metrics/reports and approve invoices; participate in vendor selection/qualification/oversight.
- Oversee CRO/vendor performance for site management; review monitoring reports, track KPIs, and escalate gaps.
- Ensure trials are executed in compliance with GCP/SOPs and applicable mandates (e.g., FDA regulations, ICG-GCP, ISO 14155).
- Review monitoring visit reports; provide investigator training, conduct monitoring visits, resolve data queries.
- Support regulatory/ethics committee activities; support QA/audits, CAPAs, and audit-ready TMF.
- Maintain shared documents/logs (e.g., issue and protocol deviation logs); support IRB submissions; keep studies on schedule and within budget.
Qualifications & Required Skills:
- Bachelor’s degree (life sciences or nursing preferred).
- 8+ years clinical research execution in medical devices.
- End-to-end medical device clinical trial experience (feasibility through inspection readiness).
- Regulatory knowledge for clinical study report submissions.
- Proven CRO/vendor oversight (selection, budgets, KPIs, escalation, invoice review) and management of in-house vs. external site models.
- Strong risk management, issue resolution, CAPA support, audit readiness/inspection preparedness.
- Excellent organizational, communication, analytical, and cross-functional skills; MS Office; EDC and CTMS experience.
- Minimal travel (~25%).
Preferred Qualifications:
- Medical aesthetics energy-based device experience; KOL/investigator relationships in aesthetics.
- CCRP or ACRP-CP certification.
- Global clinical trial management experience; deep GCP/regulatory knowledge (ISO 14155, ICH).
Benefits (as listed):
Medical (includes prescription drug), dental, vision; FSA; 401(k) match; discretionary time off; paid sick time; stock purchase plan; tuition reimbursement; parental leave; short- and long-term disability; life and accidental death & dismemberment insurance; paid holidays; referral bonuses; employee discounts.
- Own end-to-end planning and execution of a global portfolio of complex clinical research projects.
- Manage day-to-day clinical study operations: site relationships, enrollment tracking, protocol deviations, and regulatory compliance.
- Maintain study timelines/metrics; lead study-specific meetings.
- Own operational components including CRF design and TMF management.
- Partner cross-functionally (Clinical, Regulatory, Data Management, Quality, Medical Affairs) to ensure study success.
- Oversee third-party vendors: review budgets/metrics/reports and approve invoices; participate in vendor selection/qualification/oversight.
- Oversee CRO/vendor performance for site management; review monitoring reports, track KPIs, and escalate gaps.
- Ensure trials are executed in compliance with GCP/SOPs and applicable mandates (e.g., FDA regulations, ICG-GCP, ISO 14155).
- Review monitoring visit reports; provide investigator training, conduct monitoring visits, resolve data queries.
- Support regulatory/ethics committee activities; support QA/audits, CAPAs, and audit-ready TMF.
- Maintain shared documents/logs (e.g., issue and protocol deviation logs); support IRB submissions; keep studies on schedule and within budget.
Qualifications & Required Skills:
- Bachelor’s degree (life sciences or nursing preferred).
- 8+ years clinical research execution in medical devices.
- End-to-end medical device clinical trial experience (feasibility through inspection readiness).
- Regulatory knowledge for clinical study report submissions.
- Proven CRO/vendor oversight (selection, budgets, KPIs, escalation, invoice review) and management of in-house vs. external site models.
- Strong risk management, issue resolution, CAPA support, audit readiness/inspection preparedness.
- Excellent organizational, communication, analytical, and cross-functional skills; MS Office; EDC and CTMS experience.
- Minimal travel (~25%).
Preferred Qualifications:
- Medical aesthetics energy-based device experience; KOL/investigator relationships in aesthetics.
- CCRP or ACRP-CP certification.
- Global clinical trial management experience; deep GCP/regulatory knowledge (ISO 14155, ICH).
Benefits (as listed):
Medical (includes prescription drug), dental, vision; FSA; 401(k) match; discretionary time off; paid sick time; stock purchase plan; tuition reimbursement; parental leave; short- and long-term disability; life and accidental death & dismemberment insurance; paid holidays; referral bonuses; employee discounts.