At Edwards Lifesciences, a company dedicated to innovation and helping patients live longer, healthier lives, we are seeking a Senior Manager, Clinical Project Management. You will lead a critical clinical trial program focused on treatments for pediatric pulmonary valve disorders, serving as the primary lead for assigned trials.

What You'll Do

Lead a clinical trial program focused on treatments for pediatric pulmonary valve disorders.
Manage all clinical trial activities and ensure all applicable regulatory requirements are met.
Develop and manage clinical project plans to identify and complete clinical trial milestones.
Serve as the primary lead of assigned clinical trial(s).
Provide direction, guidance, and oversight of clinical core teams to execute larger or more complex projects.
Determine clinical trial resources and set priorities for projects.
Manage project status and appropriate communication both internally and externally.
May present trial information at executive and/or industry conferences.
Analyze trial performance to plan and develop corrective actions.
Identify and communicate study risks, recommending and leading the implementation of mitigation strategies.
Provide mentoring and coaching to other project team members.
Oversee the selection of clinical vendors and study sites.

What We're Looking For

Bachelor's Degree in a related field with 10 years of previous related experience, or equivalent work experience based on Edwards criteria.
Ability to travel up to 30% nationwide.

Nice to Have

Master's Degree or equivalent in a related field with 8 years of previous related experience, or equivalent work experience based on Edwards criteria.
Structural heart experience, specifically with pulmonary valve disorders.
Clinical trial experience.
Experience working in a large manufacturing company or equivalent.
Certification in a related discipline.
Proven successful project management skills.
Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File).
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management.
Expert knowledge of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols.
Expert understanding of regulatory submissions, reporting, and audits.
Ability to manage confidential information with discretion and strict attention to detail.
Ability to interact professionally with all organizational levels and proactively escalate issues.
Ability to manage competing priorities in a fast paced environment.

Technical Stack

MS Office Suite
Clinical Systems such as CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File)

Team & Environment

You will lead clinical core teams for larger or more complex projects.

Benefits & Compensation

Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of employees and their families.
Compensation range for highly experienced candidates: $139,000 - $196,000.