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Edwards Lifesciences: Staff Clinical Programmer – Transcatheter Mitral & Tricuspid Therapies (Remote

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

This is an exciting opportunity for an exceptional Staff Clinical Programmer professional with significant experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives.The Staff Clinical Programmer will be responsible for clinical data management (CDM) systems and programming, and execution for multiple clinical trials using multiple computer systems. Strong experience in Rave Electronic Data Capture (EDC) programming, database design, and custom function programming, for the development of CDM systems.The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.**This position is either located in our Irvine, CA office or remote anywhere in the USA**Essential Job Functions / Key Responsibilities: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 requirementsBasic Qualifications and Minimum Requirements:Bachelor's degree with 6 years experience OR Master’s degree with 5 years experience OR PhD with 2 years experience in clinical research, data management, software programming, or related field is requiredMedidata RAVE experience is requiredExperience within the pharmaceutical, medical device or biotech industries requiredPreferred Qualifications:Proven successful project management skillsProven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systemsExtensive 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 to 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 processesField of study in Computer Science, Information Systems/Technology, Statistics, Informatics, Mathematics, or EngineeringExtensive experience in executing complex migrationsExperience in programming complex custom functions in C#Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with the ability to drive achievement of objectivesGood presentation and facilitation skillsAbility to translate technical information to cross-functional teamsGood leadership skillsStrict 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 environmentAdditional Talents and General Expectations:Represents leadership on sections of projects within a specific area interfacing with project managers and team membersConsults in project setting within specific sectionsProvides leadership to outsourcing partners on a task levelEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences, Irvine , Edwards Lifesciences: Staff Clinical Programmer – Transcatheter Mitral & Tricuspid Therapies (Remote, Other , Irvine, California

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