Job Details

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinicalevidence to demonstrate the effectiveness and safety of our innovations and how our productstransform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosityandpassion for evaluating data to increase access to pioneering technologies for patients in need. In closepartnership with principal investigators, dedicated medical professionals, patient advocacy groups, andregulatory 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 withoutthe need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partnerwith cardiologists and clinical teams to transform patient care with devices supported by clinicalevidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of ourinspiring 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 youll make an impact:Develop and manage clinical project plansand timelinesto identify and complete clinical trial milestones with accountability for successful completion of all project deliverables in accordancewithGCP, 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 initiativesManage project status and appropriate communication both internally and externallyAnalyze 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 managementOversee the selection ofstudy sitesandclinical vendorsProvide mentoring and coaching to other project team membersWhat youll need (Required):Bachelors degree in related field with 8 years of previous experience required or equivalent work experience based on Edwards criteriaPrevious clinical research trial experience managing complex clinical studiesAbility to travel up to 30% to Irvine, CA, HeadquarterWhat else we look for (Preferred):Experience with structural heart therapeutic area; valvular therapeutic experience optimalSkilled in data analysis and storytelling with complex, aggregated datasetsProficient in understanding clinical imaging (echocardiograms, CTs)Experience working with large datasets and navigating the data cleaning processes for regulatory submissionsProven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file), and Microsoft ProjectExcellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesSkilled in clinical trial startup and early-phase execution for domestic US trialsExperience 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 coordinationKnowledge of own area within the organizationand an ability to contributeto the development of new concepts, techniques, andprocessesKnowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocolsUnderstanding of regulatory submissions, reporting, and auditsAbility to manage confidential information with discretionStrict attention to detailAbility to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organizationAbility to manage competing priorities in a fast-paced environmentRepresents leadership on sections of projects within a specific area interfacing with project managers and clinical teamAligning 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.