Senior Analyst, Clinical Programming TMTT (Remote US)

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.Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.How you will make an impact:

Design, create, validate, and modify clinical databases, and tools and programs for data validation checks, and clinical trial reporting

Lead cross functional teams in the design and delivery of moderately complex functional modules and provide data management expertise regarding clinical trials, protocols, and case report forms

Establish the development of specifications for systems and/or processes, system upgrades and enhancements; and engage IT to deliver higher level support to users

Develop and present training to end-users, including providing guidance to lower level Clinical Programmers in their training program development. End-users include, but not limited to, clinical study project teams, external clinical study users, junior-level Clinical Programmers, etc., as well as resolving escalated customer/user issues

Establish the development of SOPs, company standards, and test scripts, and verify software specifications and system configurations to ensure the quality, compatibility, compliance of clinical systems, including working with external system vendors and service providers for clinical trials

Oversee the documentation of clinical database structures, specifications, reports and other database-related tasks during the life of a clinical trial to ensure data quality and compliance with regulatory guidelines and company SOPs

Write processes, SOPs, user guides, and other user support documentation for general data management functions

What you will need (Required):

Bachelor's Degree

A minimum of 4 years’ experience related experience in clinical research, data management, software programming or related field

Ability to travel 1 time/quarter to headquarters

Proven working knowledge of Medidata Rave

Expert understanding of clinical programming procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

Expert understanding of related aspects of clinical programming processes and/or systems

What else we look for (Preferred):

Medidata Rave with custom function experience

SAS programming experience

Experience with CDISC and CDASH

Familiarity with data lake concepts

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.The base pay range for this position is $113,000 to $161,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., geographic location, 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 RequirementEdwards 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.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.