Edwards Lifesciences Principal Clinical Programmer - Transcatheter Mitral & Tricuspid Therapies 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 Principal Clinical Programmer is responsible for clinical data management (CDM) systems and programming, and execution for multiple clinical trials using multiple computer systems. Expert in programming, database design, EDC-specific programming, and applies this knowledge to the development of CDM systems.
Essential Job Functions / Key Responsibilities:
Lead the development of highly complex clinical databases, and tools and programs for data validation checks, and clinical trial reporting
Act as a SME on core business software solutions (e.g., RAVE, EDC system, CTMS) to provide novel end-to-end software solutions that improve, automate, and solve complex business process challenges
Plan and lead the design and implementation of complex functional modules and provide clinical programming expertise regarding clinical trials, protocols, and case report form with cross functional teams
Lead the development of specifications for complex systems and/or processes, system upgrades/enhancements and integration; and engage IT to deliver higher level support to users
Plan, organize, and manage internal and external clinical systems resources and activities to support clinical trials in accordance with regulatory and company guidelines. Direct the specification, documentation, validation, implementation, data archiving and retirement activities of clinical databases for clinical studies. Collaborate with cross functional teams to provide functional support to clinical study projects.
Manage internal resources and activities to facilitate collaboration with external vendors. Manage service providers’ activities for outsourced systems and services used in clinical trials.
Train and mentor internal staff to ensure the efficient operations of the clinical programming function in cross-functional projects.
Make budgetary recommendations on purchases, capital expenditures, and workforce planning.
Provide guidance 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 requirements.
Bachelor's Degree in related field with 8 years, or Master's degree or equivalent in related field with 7 years, or PhD or equivalent in related field with 4 years of previous related experience in clinical research, data management, software programming or related field.
Experience with EDC (Electronic Data Capture) systems required.
Proven successful project management skills
Proven expertise in both Microsoft Office Suite, including advanced Excel and CDM (Clinical Data Management) systems
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Excellent presentation and facilitation skills
Ability to translate complex and technical information to cross-functional teams and key leadership
Recognized as an expert in own area with specialized depth within the organization
Expert knowledge and understanding of policies, procedures and guidelines relevant in the development of clinical databases
Expert knowledge of processes and procedures in clinical data management
Expert knowledge of relational databases, systems, and programming languages
Expert knowledge of clinical programming as it relates to business processes
Strong leadership skills and ability to influence change
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to manage competing priorities in a fast paced environment
Represents leadership on projects within a specific area interfacing with project managers and team members
Consult in project setting within specific area
Provides leadership to outsourcing partners on a task level, and may participate on small scale RFP
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.