Clinical Data Associate
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. At Lilly, we serve an
extraordinary purpose. For more than 140 years, we have worked
tirelessly to discover medicines that make life better. These
discoveries start in Lilly Research Laboratories, where our
scientists work to create new medicines that will help solve our
world’s greatest health challenges. Please note, this is a hybrid
position 3 days onsite/2 days remote Purpose: This role is
responsible for trial level clinical data strategy including
database structure, content and meaning, acquisition, storage,
retrieval, interchange, delivery and representation. This requires
an in depth understanding of data collection, data flow management,
data quality, data technology, dataset delivery, archiving and data
standards. This role will collaborate with key study partners to
define, implement, and deliver clinical data management packages.
This role is responsible for providing trial leadership and
ownership for a particular trial, set of trials, or programs.
Primary Responsibilities: Portfolio Strategy, Planning and Delivery
Define Lilly business requirements for the study/program for
vendors to deliver Ensure that data management timeline and results
are delivered to scope, cost, and time objectives Perform project
monitoring and quality oversight of sourcing providers for
end-to-end data management activities – from study set up through
trial execution through dataset delivery Ensure vendor performance
for the program-level flow of data, including across niche vendors
and niche data sources (pharmacokinetic, immunogenicity, biomarker)
Drives data flow design through consultation, review, and approval
of vendor work. Ensures the data flow design is aligned with the
project hypothesis Approve key outputs and results (i.e. Data
Quality Delivery Plan, Data lock Plan, Project Plan, database, and
observed datasets) Define and approve data quality and submission
outputs and results Project Management Ensure that data
acquisition, database design, and observed dataset requirements are
reflective of specific protocol objectives Specifies the data
collection tools and technology platforms for the trial/program
Drive standards decisions, implementation and compliance for the
study/program Help create scope scenarios and negotiate outcomes
with study teams while taking into account the cost and value of
scenarios Facilitate/assimilate integration of disparate data
sources into datasets for decision making Use therapeutic knowledge
and possess a deep understanding of the technology used to review
data to ensure database deliverables are consistent and accurate
Effectively apply knowledge of applicable internal, external and
regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH,
GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
Communication Act as primary communication point for all data
management activities related to a clinical study. Report out
status of data management milestones and data quality. Partner with
external data vendors: understand specifications to import multiple
types of data, work with technical groups to ensure timely loads of
external data sets into the sponsor's database. Demonstrate
excellent written and verbal communication skills, including the
ability to represent the Data and Analytics organization and
influence stakeholders to drive data-driven decisions. Partner with
cross-functional team members to ensure trial success through
robust oversight/review. Process Improvement Continually seek and
implement means of improving processes to reduce cycle time and
decrease work effort Represent data sciences’ processes in
multi-functional initiatives. Actively engage in shared learning
across the Data and Analytics organization. Work with partners to
increase vendor/partner efficiencies Minimum Qualification
Requirements: Master’s degree in a scientific field such as
Informatics/Analytics, Life Sciences, Statistics, Information
Technology, Epidemiology, Computer Sciences (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) Other Information/Additional Preferences:
Demonstrated ability to set and implement plans to improve complex
clinical data management processes and capabilities Demonstrated
ability to effectively partner/influence a remote team and drive a
technical project to deliver results Experience with application of
clinical data management skills such as data flow, data quality &
integrity, data interchange, data mining, and data representation
principles Demonstrated ability to lead development of creative
data solutions to address clinical development challenges
Passionate about improving technological solutions using new
technologies Society of Clinical Data Management certification
Working knowledge of programming languages & Industry tools such as
Tableau, PowerBI, Python, SAS, ‘R’ and Shiny for reporting, metrics
and visualizations along with P-SQL, T-SQL for DBMS. Experience
with the following: Articulating the flow of data (structure and
format) from patient to analysis and apply this knowledge to data
solutions Utilization of clinical/drug development knowledge and an
ability to collaborate closely effectively with study team members
(i.e. Statistics, PK, Operations, Medical) Strong
therapeutic/scientific knowledge in the field of research Knowledge
of medical terminology Domestic and International travel may be
required Ability to balance multiple activities, prioritize and
manage ambiguity Demonstrated exemplary teamwork/interpersonal
skills Demonstrated problem solving, attention to detail and result
oriented behaviors in a fast-paced environment. 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 -
$140,800 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: , Bloomington , Clinical Data Associate, Science, Research & Development , Indianapolis, Indiana
