eCOA - Clinical Study Build Programmer

About the role

The Clinical Study Build Programmer - eCOA is responsible for programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This role requires an in-depth understanding of data technology, data flow, data standards, database programming, normalization and testing.

Responsibilities

• Proficiency in programming and configuring clinical data collection systems (e.g., eCOA/EDC platforms)
• Study build programming expertise (e.g., form logic, edit checks, workflows, integrations)
• Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
• Gather and influence eCOA design specifications and enable successful implementation
• Understand study translation needs and enable localization
• Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives
• Provide insights into the study design and data delivery (i.e. Data Management Plan, Project Plan, database, and observed datasets)
• Support submission, inspection and regulatory response activities
• Lead cross Business Unit/Therapeutic Area projects or programs with high complexity

Requirements

• Master’s degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences
• + 3 years of related experience (or bachelor’s degree plus 5 or more years of experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc...)

Qualifications

• Experience with designing and handling eCOA data
• Deciding the technology platform (system/database) for data acquisition and aggregation
• Strong therapeutic/scientific knowledge in the field of research
• Familiarity with clinical data tools and technologies
• Understanding and experience in using data standards

Skills

• Strong therapeutic/scientific knowledge in the field of research
• Familiarity with clinical data tools and technologies
• Understanding and experience in using data standards

Benefits

• Comprehensive benefit program including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

$79,500 - $169,400

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).