Want to know if this job is worth applying to?
Irvine, California, United States
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Clinical Project Manager based in the United States.
Take on a senior clinical operations role overseeing complex clinical trials that support the safety and effectiveness of innovative medical devices. You will lead global clinical projects from planning through execution, ensuring milestones, budgets, quality standards, and regulatory expectations are consistently met. Working closely with investigators, clinical sites, CROs, vendors, and cross-functional teams, you will help deliver reliable study outcomes and maintain inspection-ready documentation. Your expertise will contribute to clinical strategy, operational excellence, and strong relationships with medical professionals and research partners. You will also serve as a clinical operations subject matter expert, supporting audits, mentoring colleagues, and improving processes across the organization. This is an opportunity to contribute to meaningful medical innovation in a collaborative, internationally connected environment.
Lead and coordinate one or more complex clinical trials, taking accountability for project strategy, planning, execution, and delivery.
Maintain continuous audit readiness across clinical projects, including team training records, central files, system validation, and other required documentation.
Serve as the primary front-room lead during clinical study audits, including mock audits and inspections conducted by regulatory authorities.
Leverage expertise, resources, and relationships across projects to ensure deliverables and milestones are achieved on time.
Maintain effective communication across clinical project teams, functional managers, and senior leadership, serving as a Clinical Operations subject matter expert.
Develop, manage, and monitor clinical project budgets and timelines.
Support the selection, contracting, coordination, and oversight of CROs, vendors, and contractors.
Oversee the development of clinical project deliverables, including study manuals, operational plans, and study tools.
Compile proposed investigational site lists and participate in the review and approval of clinical research sites.
Visit investigational sites to strengthen clinical relationships and improve collaboration with investigators and site teams.
Coordinate clinical device forecasting in partnership with supply chain teams to ensure appropriate product availability for each project.
Support and attend investigator and coordinator meetings, representing the clinical project team.
Prepare and present clinical project status updates to clinical management.
Develop and oversee corrective action plans for individual sites and across trials, and participate in internal or external trial-related audits as needed.
Ensure clinical research activities comply with applicable laws, regulations, standards, and internal SOPs and policies.
Mentor and train team members, sharing clinical operations expertise and best practices.
Contribute to non-trial initiatives, including process improvement and procedure development teams.
Bachelor’s degree required; a degree in a science or healthcare-related field, such as Biology, Nursing, Biomedical Science, Pharmacy, or Veterinary Sciences, is preferred.
At least 8 years of experience in clinical or scientific research, nursing, medical devices, or pharmaceutical clinical trials.
Demonstrated ability to independently manage multiple complex clinical projects across global environments.
Strong understanding of clinical research conduct, applicable regulations, quality standards, and clinical trial operations.
Analytical skills, including the ability to collect and assess research data, interpret information, and communicate findings to relevant stakeholders.
Strong organizational and project management capabilities, with the ability to manage competing priorities, budgets, timelines, and deliverables.
Excellent problem-solving skills, including the ability to gather and analyze information, develop alternatives, and collaborate on solutions.
Strong oral communication and presentation skills, with the confidence to engage medical professionals, investigators, senior leadership, and cross-functional teams.
Excellent written communication skills, with the ability to prepare clear, accurate, and persuasive project documentation and status reports.
Adaptability and dependability, including the ability to respond constructively to changing priorities, delays, and unexpected challenges while maintaining commitments.
Creative and innovative mindset, with the ability to identify opportunities for improvement and develop practical solutions.
Self-motivation, persistence, and a strong commitment to achieving challenging goals.
Collaborative approach and alignment with organizational goals and values.
Annual salary range: $150,000–$170,000 USD.
Work arrangement: Remote, with occasional travel to company offices, clinical research sites, and conferences.
Location reference: Irvine, California.
Travel: Approximately 20% domestic and international travel.
The source description does not specify additional benefits such as healthcare coverage, retirement plans, paid time off, or bonus eligibility.