Principal, Clinical Programming, Surgical

Edwards Lifesciences • Irvine, CA

4d • $132,000 - $186,000 • Hybrid

About The Position

The Principal, Clinical Programming role is part of the Clinical Affairs team supporting the Surgical business unit. The position provides technical expertise in clinical programming and leads the development of clinical databases, data validation tools and programs, and clinical trial reporting in collaboration with key stakeholders. It leads cross-functional teams in designing and delivering complex functional modules and advises on clinical trials, protocols, and case report forms.

The role develops specifications for systems and processes, system upgrades and enhancements, and integrations, and works with IT to provide higher-level user support. It also develops and presents technical training for end users, guides lower-level Clinical Programmers in developing training programs, identifies resources needed for database implementation, evaluates external vendors, and manages service providers supporting outsourced clinical trial systems and services. The position contributes to SOPs and other controlled documents to ensure clinical systems and activities meet regulatory and company requirements.

Requirements

• Bachelor’s degree and at least 6 years of experience in clinical research, data management, software programming, or a related field, or equivalent work experience based on Edwards criteria.
• Extensive experience with electronic data capture (EDC) systems.
• Medidata programming experience.

Nice To Haves

• Master’s degree and at least 5 years of experience in clinical research, data management, software programming, or a related field, or equivalent work experience based on Edwards criteria; or a Ph.D. and at least 2 years of such experience.
• Expertise creating new and maintaining existing Medidata custom functions in C# or SQL.
• Proven project management skills.
• Expertise in Microsoft Office Suite, including advanced Excel, and clinical data management (CDM) systems.
• Excellent documentation, communication, and interpersonal relationship skills, including negotiation and relationship management skills and the ability to drive achievement of objectives.
• Good presentation and facilitation skills.
• Ability to translate technical information for cross-functional teams.
• Extensive knowledge of the role’s organizational area and contribution to developing new concepts, techniques, and standards.
• Extensive knowledge of policies, procedures, and guidelines relevant to clinical database development.
• Extensive knowledge of clinical data management processes and procedures.
• Extensive knowledge of relational databases, systems, and programming languages.
• Extensive knowledge of clinical programming as it relates to business processes.
• Ability to manage competing priorities in a fast-paced environment.

Responsibilities

• Provide clinical programming expertise and lead development of clinical databases, data validation tools and programs, and clinical trial reporting in collaboration with stakeholders.
• Lead cross-functional teams in the design and delivery of complex functional modules; provide expertise on clinical trials, protocols, and case report forms.
• Develop specifications for systems and processes, upgrades and enhancements, and integrations; engage IT to provide higher-level user support.
• Develop and present technical training to end users and guide lower-level Clinical Programmers in training program development.
• Identify resource needs for database implementation and participate in evaluating external resources and vendors.
• Manage daily service-provider activities for outsourced systems and services used in clinical trials.
• Participate in creating and revising SOPs, work instructions, workflows, forms, and templates to support compliance with regulatory and company requirements.
• Represent leadership on project sections within a specific area, interfacing with project managers and team members.

Benefits

• Competitive salaries.
• Performance-based incentives.
• A wide variety of benefits programs to address the diverse individual needs of employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal