Principal, Clinical Programming, Surgical

healthier lives. Join us and be part of our inspiring journey.How you will make an impact:Provide technical expertise in clinical programming functional area and lead in the development of clinical databases, and tools and programs for data validation checks, and clinical trial reporting in collaboration with key stakeholdersLead cross functional teams in the design and delivery of complex functional modules and provide clinical programming expertise regarding clinical trials, protocols, and case report formsLead the development of specifications for systems and/or processes, system upgrades/enhancements and integration; and engage IT to deliver higher level support to usersDevelop and present high level technical training to end-users, including providing guidance to lower-level Clinical Programmers in their training program developmentIdentify resource needs for database implementation and participate in the evaluation of external resources/vendorsManage daily service providers'

activities for outsourced systems and services used in clinical trialsParticipate in the creation and revision of new or existing SOPs, work instructions, workflow, forms, and templates to ensure clinical systems and activities are in compliance with the regulatory and company requirementsWhat you will need (Required):Bachelor's Degree and a minimum of 6 years experience in clinical research, data management, software programming or related field or equivalent work experience based on Edwards criteria Extensive experience with EDC (Electronic Data Capture) systems; Medidata programming experienceWhat else we look for (Preferred):Master's Degree and a minimum of 5 years experience in clinical research, data management, software programming or related field or equivalent work experience based on Edwards criteria OR a Ph.D. and a minimum of 2 years experience in clinical research, data management, software programming or related field or equivalent work experience based on
Edwards criteriaExpert knowledge in creating new and maintaining existing Medidata custom functions in C# or SQL.Proven successful project management skillsProven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systemsExcellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesGood presentation and facilitation skillsAbility to translate technical information to cross-functional teamsExtensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standardsExtensive knowledge and understanding of policies, procedures and guidelines relevant in the development of clinical databasesExtensive knowledge of processes and procedures in clinical data managementExtensive knowledge of relational databases, systems, and programming

languagesExtensive knowledge of clinical programming as it relates to business processesAbility to manage competing priorities in a fast-paced environmentRepresents leadership on sections of projects within a specific area interfacing with project managers and team membersAligning 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 $132,000 - $186,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). #LI-Hybrid Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve
patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. #J-18808-Ljbffr