Senior Manager, Clinical Trials

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

Benefits offered by this job

Medical (includes Prescription Drug)

Dental

Vision

401(k) with matching company contrib.

Discretionary time off

Paid sick time

Stock purchase plan

Tuition reimbursement

Parental leave

Short-term and long-term disability

Life insurance

AD&D insurance

Paid holidays

Employee referral bonuses

Employee discounts

Job summary

Solta is seeking a Senior Manager, Clinical Trials to lead end-to-end planning and execution of a portfolio of complex clinical research projects globally. You will manage day-to-day study operations, site relationships, enrollment tracking, and regulatory compliance across multiple sites.

You will oversee CROs and vendors, ensure adherence to timelines and budgets, and coordinate cross-functionally with Clinical, Regulatory, Data Management, Quality, and Medical Affairs.

Qualifications

• Bachelor's 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.
• Understanding of regulatory requirements for clinical study report submissions.
• Experience overseeing CROs, vendors, and external partners with budgeting and KPI oversight.
• Ability to manage in-house and external site models and escalate risks.
• Strong organizational and cross-functional collaboration skills.

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, site relationships, enrollment tracking and regulatory compliance across sites.
• Manage study timelines and metrics and ensure adherence.
• Lead study-specific meetings and manage CRF design and TMF.
• Partner cross-functionally to ensure study success.
• Oversee third-party vendors, budgets, and invoices against approved budgets.
• Ensure trials comply with GCP, SOPs, FDA regulations, ISO 14155.
• Develop and maintain study budgets, contracts, and logs.
• Prepare study documents and support IRB submissions.

Skills

GCP knowledge

Project management

Cross-functional collaboration

MS Office

EDC systems

CTMS platforms

Risk management

Excellent communication

Education

Bachelor's degree in life sciences or nursing

Tools

MS Office

EDC systems

CTMS platforms

Job description

Senior Manager, Clinical Trials

Job Location: Irvine, USA | SanFrancisco, USA | Boston, USA | Bothell, USA

Job Requisition ID: 15543

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

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

• 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
• par ental leave
• short-term and long-term disability
• life insurance
• accidental death & dismemberment insurance
• paid holidays
• employee referral bonuses
• employee discounts

We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.