eCOA - Clinical Study Build Programmer

Summary

Eli Lilly and Company is a pharmaceutical organization focused on discovering and delivering life-changing medicines. The Clinical Study Build Programmer - eCOA programs and tests clinical trial data collection databases, maps and normalizes data into clinical data warehouses, and collaborates with cross-functional teams to support global clinical trials, regulatory activities, and complex projects.

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
• Possess a deep understanding of the technology used to collect clinical trial data
• Develops and tests new ideas and/or applies innovative solutions
• Increase speed, accuracy, and consistency in the development of systems solutions
• Enable metrics reporting of study development timelines and pre and post production changes to database
• 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
• 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
• Work to reduce postproduction changes change control process
• Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization
• Thinks with end to end in mind consistently managing risk to minimize impact on delivery
• Strong awareness with external developments, timelines
• Focuses on defining database solutions and timelines in support of advancing the portfolio

Skills

• * 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...)
• * 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)
• * Possess a deep understanding of the technology used to collect clinical trial data
• * 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
• * Strong awareness with external developments, timelines
• * Understanding and experience in using data standards
• * Ability to balance multiple activities, prioritize and manage ambiguity
• * Domestic and International travel may be required
• * 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

Qualifications

Must Haves

• * 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...)
• * 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)
• * Possess a deep understanding of the technology used to collect clinical trial data
• * 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
• * Strong awareness with external developments, timelines
• * Understanding and experience in using data standards
• * Ability to balance multiple activities, prioritize and manage ambiguity
• * Domestic and International travel may be required

Nice to Haves

• * 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

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Eligibility to participate in a company-sponsored 401(k)
• Pension
• Vacation benefits
• Eligibility for medical, dental, vision and prescription drug benefits
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities
• Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.