Senior Manager, Clinical Trials

Senior Manager, Clinical Trials

Job Location:

Irvine, USA  | San Francisco, USA  | Boston, USA  | Bothell, USA

Job

Requisition

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.

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…