Edwards Lifesciences Senior Clinical Programmer - Transcatheter Mitral & Tricuspid Therapies (Remote) in Irvine, California
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.
The Senior Clinical Programmer will be responsible for developing programs and databases that facilitate the collection and retrieval of clinical trial data for regulatory submissions and marketing claims.
Essential Job Functions / Key Responsibilities:
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
Basic Qualifications and Minimum Requirements:
Bachelor's degree with 4 years of previous Medidata RAVE clinical programming experience in the pharmaceutical, medical device or biotech industries.
Proven expertise in Microsoft Office Suite
Basic project management skills
Full knowledge and understanding of policies, procedures and guidelines relevant in the development of clinical databases
Full knowledge of processes and procedures in clinical data management
Full knowledge of relational databases, systems, and programming languages
Fields of study in Computer Science, Information Systems/Technology, Statistics, Informatics, Mathematics or Engineering
Extensive experience in migrations
Experience in programming simple custom functions in C#
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
Excellent problem-solving and critical thinking skills
Ability to manage competing priorities in a fast-paced environment
Strict attention to detail
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.