Global Clinical Project Management Lead

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

Benefits offered by this job

Competitive salary

Performance-based incentives

Comprehensive benefits

Job summary

Edwards Lifesciences Gruppe seeks a Manager of Clinical Project Management THV Global Clinical Research to lead trial activities and ensure regulatory compliance. The role requires synthesizing large trial data to support operational strategies and oversight of complex, global studies.

Ideal candidates have a strong background in regulatory submissions, CTMS/eTMF, and senior project management within a manufacturing or medical device environment.

Qualifications

• Bachelor's Degree in related field; 10 years of related experience or equivalent.
• Master's Degree in related field preferred.
• Experience with CTMS and eTMF systems preferred.
• Excellent written and verbal communication and interpersonal skills including negotiation.

Responsibilities

• Lead management of THV global clinical trials in compliance with GCP and regulations.
• Oversee clinical core teams; set priorities and milestones for complex projects.
• Ensure regulatory submissions, audits, and SOP adherence across trials.
• Manage vendors and study sites; provide guidance to outsourcing partners.
• Mentor and coach project team members and communicate study status.

Skills

Leadership

Communication

Project management

Interpersonal skills

Negotiation

Education

Bachelor's Degree in related field

Master's Degree preferred

Tools

CTMS

eTMF

MS Office Suite

Job description

Edwards Lifesciences Gruppe seeks a Manager of Clinical Project Management THV Global Clinical Research to lead trial activities and ensure regulatory compliance. The role requires synthesizing large trial data to support operational strategies and oversight of complex, global studies.

Ideal candidates have a strong background in regulatory submissions, CTMS/eTMF, and senior project management within a manufacturing or medical device environment.