Senior Manager, Clinical Trials
Job Location: Bothell, USA
Job Requisition ID: 15543
The Senior Clinical Project Manager is responsible for the operational management and execution of clinical trials, ensuring studies are delivered on time, within budget, and in compliance with regulatory, ethical, and company standards. This role manages the end-to-end operational aspects of feasibility, pilot, and pivotal clinical trials. This individual owns operational execution of device studies required for marketing claims and regulatory submissions - including site management, vendor management, protocol adherence, enrollment tracking, data integrity and clinical package generation. Acts as the day-to-day engine of Solta's clinical research function, ensuring studies are delivered on time and to regulatory standard.
The position works cross-functionally with Medical Affairs, Clinical Development, Regulatory Affairs, Compliance, Legal, Finance, Procurement, Commercial, and external partners to ensure efficient and compliant execution of clinical operations activities globally.
This role requires a highly organized and self-motivated individual with demonstrated project management capabilities, strong attention to detail, and the ability to manage multiple trials simultaneously while ensuring timely execution and completion of key deliverables.
Responsibilities:
Project Ownership:
• 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 managing site relationships, tracking enrollment, resolving protocol deviations, and ensuring regulatory compliance across all sites.
• Manage comprehensive study timelines and metrics and oversees adherence to them.
• Plan, execute, and/or lead study-specific meetings (e.g., study team meetings, 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.
Vendor Management:
• Oversee third-party vendors; reviews vendor reports, budgets, and metrics; reviews and approves clinical vendor invoices against the approved budget.
• Participate in vendor selection, qualification, and ongoing oversight planning
• Oversee CRO and external vendor performance related to site management activities, including review of monitoring visit reports, tracking of key performance indicators, and escalation of performance gaps
Compliance Management:
• Ensure all clinical trials are executed in compliance with international GCP guidelines/regulations and applicable SOPs
• Review monitoring visit reports to ensure quality and resolution of site-related issues; participates in site monitoring visits, as appropriate
• Coordinate and assists in the planning of regulatory or ethics committee activities, as appropriate
• Serve as primary site contact for clinical investigators: provide device protocol training, conduct monitoring visits, and resolve data queries.
• Collaborate with the planning of quality assurance activities and coordinates resolution of audit findings and CAPAs; ensures audit-ready condition of clinical trial documentation including the TMF
• Ensure all trials follow international and local mandates like FDA regulations, ICG-GCP, and ISO 14155.
Documentation and Execution:
• Maintain integrated clinical study timelines, proactively flagging risks and potential delays to Solta Clinical Development Lead.
• Develop operating budgets, track expenses, negotiate site/vendor contracts and proactively mitigate financial or operational variances.
• Develop clinical trial documents and support IRB submissions.
• Prepares and maintains necessary shared documents, reports, and logs (e.g., Study and Site Issue Log, Protocol Deviation Log).
• Ensure trials are completed on schedule and within budget from study initiation through close-out.
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.
• Demonstrated experience leading end to end clinical trial execution in medical devices, including: feasibility, start up, enrollment, monitoring, close out and inspection readiness.
• Understanding of regulatory authority requirements for clinical study report submissions
• Experience overseeing CROs, clinical vendors, and external partners, including vendor selection, budget oversight, performance metrics, issue escalation, and invoice review
• Proven ability to manage both in-house and external CRO site models, with understanding of when to use each.
• Proven ability to manage and oversee clinical sites, including startup, activation, enrollment support, and ongoing site performance.
• Demonstrated ability to identify risks, proactively problem-solve, and escalate appropriately to ensure study timelines and objectives are met; Demonstrated strength in risk management, issue resolution, CAPA support, audit readiness, and inspection preparedness
• Excellent organizational, communication, interpersonal, and cross-functional collaboration skills.
• Strong analytical and problem-solving capabilities.
• Flexible and focused under dynamic, fast-paced conditions.
• Strong organizational and project management skills, with the ability to prioritize, multi-task, and deliver high-quality work in a fast-paced environment.
• Excellent written and verbal communication skills, with the ability to effectively present information, provide clear direction, and engage with investigators and site staff.
• Self-motivated, detail-oriented, and able to work both independently and within a highly interdependent team structure.
• Proficiency with MS Office; experience with EDC systems and CTMS platforms
• Minimal travel required (approximately 25%), primarily for meetings at headquarters, clinical site visits, or other business needs.
Preferred Qualifications
• Experience in the medical aesthetics energy-based device industry.
• Existing KOL networks or investigator community relationships in aesthetics.
• Industry certifications such as CCRP (Certified Clinical Research Professional) or ACRP-CP are highly valued.
• Global clinical trial management experience
• In-depth understanding of Good Clinical Practice (GCP) and applicable regulations, including ISO 14155, ICH Guidelines, and relevant medical device directives/regulations.
The range of starting base pay for this role is 158K - 218K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.
Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.
