Global Clinical Trials Lead – THV Program

Edwards Lifesciences; Irvine (CA); On-site; USD 139,000 - 196,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, is seeking a Manager of Clinical Project Management THV Global Clinical Research to oversee clinical trials activities, ensure regulatory compliance, and guide cross-functional teams through complex studies.

You will lead trial plans, coordinate vendors and sites, manage risks and milestones, and mentor project team members, with emphasis on GCP, regulatory submissions, and collaboration with executive leadership.

Qualifications

• Bachelor's degree in related field required with 10 years of relevant experience or equivalent.
• Master's degree preferred or equivalent.
• Experience in a large manufacturing company or equivalent.
• Certification in related discipline preferred.
• Proven project management skills and ability to lead cross-functional teams.

Responsibilities

• Manage clinical trials activities and ensure regulatory requirements are met.
• Synthesize clinical trial data to support operational strategies.
• Oversee long-term IDE and Post-approval trials in a matrix organization.
• Develop and manage clinical project plans with milestones and deliverables.
• Lead assigned trials, provide direction to clinical core teams, and oversee external vendors and sites.
• Identify risks, develop mitigation strategies, and communicate with leadership.
• Mentor and coach project team members and collaborate with executives.

Skills

Project management

MS Office

Communication skills

Leadership

Regulatory knowledge

Education

Bachelor's degree in related field

Master's degree

Tools

CTMS

eTMF

Clinical Systems

Job description

Edwards Lifesciences in Irvine, CA, is seeking a Manager of Clinical Project Management THV Global Clinical Research to oversee clinical trials activities, ensure regulatory compliance, and guide cross-functional teams through complex studies.

You will lead trial plans, coordinate vendors and sites, manage risks and milestones, and mentor project team members, with emphasis on GCP, regulatory submissions, and collaboration with executive leadership.