Senior Analyst, EDC Database Validation - Transcatheter Mitral & Tricuspid Therapies

Company: Edwards Lifesciences Corp
Location: Irvine
Posted on: June 10, 2021

Job Description:

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 Sr. Analyst, EDC Database Validation will be responsible for managing data validation activities using EDC (electronic data capture) systems for multiple clinical trials. The individual in this role will be an expert in validation with skills to plan validation activities, develop validation scripts, execute scripts with the help of data coordinators, identify programming issues during testing and UAT, and address issues in collaboration with the programming team. The role requires a sound knowledge of Medidata RAVE database design and build, and clinical data management skills.

Location: Irvine CA

Essential Job Functions / Key Responsibilities:

• Develop test scripts, review tests scripts with data managers, prepare test plan and reports for database validation and/or user acceptance testing to ensure accuracy of database structure and appropriate data is collected with proper validation.
• Provide insights, identify validation issues and partner with stakeholders (e.g., programmers, data managers, and data coordinators) to address and resolve issues.
• Create validation summaries and reports and provide insights into the validation to ensure project deliverables and timelines are met in collaboration with internal team, Data Management, Programming, Clinical Affairs
• Create and update functional specifications for the validation tool (e.g., SAS program) using specialized technical knowledge
• Author and execute validation scripts for clinical reports
• Perform study database design and build programming activities
• Assist in creating clinical listings and reports for data managers
• Other incidental duties

Basic Qualifications and Minimum Requirements:

• Bachelor's degree
• 4 years of programming or EDC validation experience
• Experience with Medidata RAVE EDC system
• Full knowledge and understanding of policies, procedures and guidelines relevant to EDC validation
• Proven expertise in Microsoft Office Suite
• Full knowledge of processes and procedures in clinical data management

Full knowledge of relational databases, systems, and programming languages

Preferred Qualifications:

• Field of study in Computer Science, Information Systems/Technology, Statistics, Informatics, or Clinical Research
• Rave programming experience in clinical trials within the pharmaceutical, medical device or biotech industry
• SAS programming experience
• Basic project management skills
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Excellent problem-solving and critical thinking skills
• 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
• Strict attention to detail
• Ability to manage competing priorities in a fast-paced environment
• Adhere to department SOPs and a regulated environment

About Edwards Lifesciences

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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences Corp, Irvine , Senior Analyst, EDC Database Validation - Transcatheter Mitral & Tricuspid Therapies, Other , Irvine, California