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 levels and proactively escalate issues to appropriate levels of management in the organization

Ability to manage competing priorities in a fast-paced environment

Represents leadership on sections of projects within a specific area interfacing with project managers and clinical team

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $118,000 to $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.