Senior Manager, Clinical Trials

Locations: Irvine, San Francisco, Boston, or Bothell, USA

About the role

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. Be a part of a culture that actively creates change—where your skills and values drive collective progress and impact. 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, including site management, vendor management, protocol adherence, enrollment tracking, data integrity, and clinical package generation for marketing claims and regulatory submissions.

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 site relationships, enrollment tracking, protocol deviations, and regulatory compliance. Oversee comprehensive study timelines and metrics, and lead study-specific meetings (e.g., study team meetings, investigator meetings). Own operational components such as CRF design and TMF management. Partner cross-functionally with Clinical, Regulatory, Data Management, Quality, and Medical Affairs to ensure alignment and study success.
• Vendor Management: Oversee third-party vendors, including reviewing vendor reports, budgets, and metrics. Approve clinical vendor invoices against the approved budget. Participate in vendor selection, qualification, and ongoing oversight. Oversee CRO and external vendor performance related to site management, including review of monitoring visit reports and tracking key performance indicators.
• 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. Coordinate regulatory or ethics committee activities. Serve as primary site contact for clinical investigators, providing protocol training, conducting monitoring visits, and resolving data queries. Collaborate on quality assurance activities and ensure audit-ready condition of clinical trial documentation, including the TMF. Ensure compliance with FDA regulations, ICH-GCP, and ISO 14155.
• Documentation and Execution: Maintain integrated clinical study timelines, proactively flagging risks and potential delays. Develop operating budgets, track expenses, negotiate site/vendor contracts, and mitigate financial or operational variances. Develop clinical trial documents and support IRB submissions. Prepare and maintain 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 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.
• 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.
• 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 project management skills, with the ability to prioritize, multi-task, and deliver high-quality work.
• Excellent written and verbal communication skills, with the ability to present information 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.
• 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.

Pay

The range of starting base pay for this role is $158,000 – $218,000. Actual starting pay will be based on relevant skills, experience, qualifications, education, and location. In addition to base pay, this position is eligible for participation in either our annual bonus program or a sales incentive plan.

Benefits

• Comprehensive medical, dental, and vision coverage (includes prescription drug benefits).
• Flexible Spending Accounts.
• 401(k) with matching company contribution.
• Discretionary time off and paid sick time.
• Stock purchase plan.
• Tuition reimbursement.
• Parental leave.
• Short-term and long-term disability insurance.
• Life insurance and accidental death & dismemberment insurance.
• Paid holidays.
• Employee referral bonuses and employee discounts.