Clinical Study Build Programmer - eCOA
Location: Indianapolis
Posted on: June 23, 2025
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Job Description:
At Lilly, we unite caring with discovery to make life better for
people around the world. We are a global healthcare leader
headquartered in Indianapolis, Indiana. Our employees around the
world work to discover and bring life-changing medicines to those
who need them, improve the understanding and management of disease,
and give back to our communities through philanthropy and
volunteerism. We give our best effort to our work, and we put
people first. We’re looking for people who are determined to make
life better for people around the world. 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 requires an in-depth understanding of data technology, data
flow, data standards, database programming, normalization and
testing. The Clinical Study Build Programmer will collaborate with
Data and Analytics colleagues such as the Clinical Data Associate,
Clinical Data Manager and other key business partners to deliver
standardized data collection methods and innovative validation
solutions for use in global clinical trials. Portfolio Delivery
Gather and influence eCOA design specifications and enable
successful implementation 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
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 Project Management Increase speed,
accuracy, and consistency in the development of systems solutions
Enable metrics reporting of study development timelines and pre and
postproduction 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 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 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 Minimum Qualification 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)
Additional Preferences: 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
Understanding and experience in using data standards Ability to
balance multiple activities, prioritize and manage ambiguity
Domestic and International travel may be required Lilly is
dedicated to helping individuals with disabilities to actively
engage in the workforce, ensuring equal opportunities when vying
for positions. If you require accommodation to submit a resume for
a position at Lilly, please complete the accommodation request form
( https://careers.lilly.com/us/en/workplace-accommodation ) for
further assistance. Please note this is for individuals to request
an accommodation as part of the application process and any other
correspondence will not receive a response. Lilly is proud to be an
EEO Employer and does not discriminate on the basis of age, race,
color, religion, gender identity, sex, gender expression, sexual
orientation, genetic information, ancestry, national origin,
protected veteran status, disability, or any other legally
protected status. Our employee resource groups (ERGs) offer strong
support networks for their members and are open to all employees.
Our current groups include: Africa, Middle East, Central Asia
Network, Black Employees at Lilly, Chinese Culture Network,
Japanese International Leadership Network (JILN), Lilly India
Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ
Allies), Veterans Leadership Network (VLN), Women’s Initiative for
Leading at Lilly (WILL), enAble (for people with disabilities).
Learn more about all of our groups. Actual compensation will depend
on a candidate’s education, experience, skills, and geographic
location. The anticipated wage for this position is $63,000 -
$162,800 Full-time equivalent employees also will be eligible for a
company bonus (depending, in part, on company and individual
performance). In addition, 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).Lilly reserves the
right to amend, modify, or terminate its compensation and benefit
programs in its sole discretion and Lilly’s compensation practices
and guidelines will apply regarding the details of any promotion or
transfer of Lilly employees. WeAreLilly
Keywords: , Indianapolis , Clinical Study Build Programmer - eCOA, Science, Research & Development , Indianapolis, Indiana
