Manager, Clinical Project Management

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

As the Manager of Clinical Project Management, you will manage clinical trials activities and ensure all applicable regulatory requirements are met. This role requires the ability to synthesize large sets of clinical trial data to support innovative operational strategies. The ideal candidate will be proficient in data analysis and skilled in translating complex aggregate data into compelling narratives. Experience working with large datasets and navigating the data cleaning process for regulatory submissions is essential.

How you'll make an impact:

• Develop and manage clinical project plans and timelines to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables in accordance with GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s)

• Provide direction, guidance, and oversight of clinical core teams to execute projects and initiatives

• Manage project status and appropriate communication both internally and externally

• Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in collaboration with management

• Oversee the selection of study sites and clinical vendors

• Provide mentoring and coaching to other project team members

What you'll need (Required):

• Bachelor's degree in related field with 8 years of previous experience required or equivalent work experience based on Edwards criteria

• Previous clinical research trial experience managing complex clinical studies

• Ability to travel up to 30% to Irvine, CA, Headquarter

What else we look for (Preferred):

• Experience with structural heart therapeutic area; valvular therapeutic experience optimal

• Skilled in data analysis and storytelling with complex, aggregated datasets

• Proficient in understanding clinical imaging (echocardiograms, CTs)

• Experience working with large datasets and navigating the data cleaning processes for regulatory submissions

• Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file), and Microsoft Project

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Skilled in clinical trial startup and early-phase execution for domestic US trials

• Experience with RAVE databases (e.g. report/listing generation, query review, and database migration process)

• Former work experience supporting cath lab coordination or valve clinic research coordination

• Knowledge of own area within the organization and an ability to contribute to the development of new concepts, techniques, and processes

• Knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols

• Understanding of regulatory submissions, reporting, and audits

• Ability to manage confidential information with discretion

• Strict attention to detail

• Ability to interact professionally with all organizational l