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, Clinical Project Management, on the Pulmonic team, you manage clinical trials activities and ensure all applicable regulatory requirements are met.

　　The position will be on-site at our Irvine headquarter.

　　You will make an impact by...

　　• Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables in accordance to 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 clinical vendors and study sites

　　• Provide mentoring and coaching to other project team members

　　• Other incidental duties

　　What you'll need (Required):

　　Bachelor's Degree in related field8 years of medical device/pharma/CRO clinical research experience managing complex clinical studiesAbility to travel domestically up to 20% for conferences, clinical site visits etc...Covid vaccination

　　What else we look for (Preferred):

　　• Experience with structural heart therapeutic area

　　• 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

　　• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards

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

　　• Extensive 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 $106,000 to $151,000 (highly experienced).

　　The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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

　　COVID Vaccination Requirement

　　Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.