Senior Global Medical Device Clinical Trials Lead

Bausch Health Companies Inc.; Bothell (WA); On-site; USD 158,000 - 218,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

Vision care

401(k) with company match

Paid time off

Job summary

Solta seeks a Senior Clinical Project Manager to lead global clinical research projects for medical device trials. You will manage site relationships, enrollment, and regulatory compliance, ensuring on-time, on-budget delivery while maintaining data integrity and TMF readiness.

You will coordinate cross-functional teams across Medical Affairs, Regulatory, Data Management, and QA to ensure study success, with about 25% travel.

Qualifications

• Bachelor's degree required; degree in life sciences or nursing preferred
• Minimum of 8 years of clinical research execution in the medical device industry
• Experience leading end-to-end clinical trial execution in medical devices (feasibility, startup, enrollment, monitoring, close-out)
• Understanding regulatory requirements for clinical study report submissions
• Experience overseeing CROs, vendors, and external partners; budget oversight and invoice review
• Ability to manage both in-house and external CRO site models and to escalate risks as needed
• Strong organizational, communication, and cross-functional collaboration skills
• Proficiency with MS Office; experience with EDC systems and CTMS
• Travel approximately 25% for meetings, site visits, and business needs

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, and regulatory compliance
• Oversee study timelines and metrics; lead study-specific meetings
• Own operational components such as CRF design and TMF management
• Partner cross-functionally to ensure study alignment and success
• Oversee third-party vendors; review budgets and vendor invoices
• Coordinate regulatory or ethics committee activities and monitor audit readiness

Skills

Project management

Clinical operations

Cross-functional collaboration

Regulatory compliance

Vendor management

Risk management

Budgeting

Education

Bachelor's degree in life sciences or nursing

Tools

MS Office

EDC systems

CTMS

Job description

Solta seeks a Senior Clinical Project Manager to lead global clinical research projects for medical device trials. You will manage site relationships, enrollment, and regulatory compliance, ensuring on-time, on-budget delivery while maintaining data integrity and TMF readiness.

You will coordinate cross-functional teams across Medical Affairs, Regulatory, Data Management, and QA to ensure study success, with about 25% travel.