eCOA - Clinical Study Build Programmer

About the role

The Clinical Study Build Programmer - eCOA is responsible for programming and sing clinical trial data collection databases, including the mapping, sing and normalization of data into a clinical data warehouse. This role collaborates with Data and Analytics colleagues to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.

Responsibilities

• Portfolio Delivery
  • 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 s 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
  • 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
• Enterprise Leadership
  • Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis
  • Reduce postproduction changes change control process
  • Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization
  • Think with end to end in mind consistently managing risk to minimize impact on delivery
  • Strong awareness with external developments, timelines
  • Balance multiple activities, prioritize and manage ambiguity

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
• Articulating the flow of data (structure and format) from patient to analysis, applying this knowledge to data solutions
• Deciding the technology platform (system/database) for data acquisition and aggregation
• Utilization of clinical/drug development knowledge and an ability to liaise with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical, etc.)
• Strong therapeutic/scientific knowledge in the field of research
• Familiarity with clinical data tools and technologies
• Ability to balance multiple activities, prioritize and manage ambiguity

Skills

• Deep understanding of the technology used to collect clinical trial data
• Develops and ss new ideas and/or applies innovative solutions
• Project Management
  • Increase speed, accuracy, and consistency in the development of systems solutions
  • Partner with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Management Associate to deliver study database per business need and before first patient visit
  • Influence data standard decisions and strategies for a study and/or program
  • Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study database building
  • Integrates multi-functional, external information and technical knowledge to support data-driven decision making

Benefits

Lilly offers a comprehensive benefit program to eligible employees, 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

The anticipated wage for this position is $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).