Eli Lilly and Company · 18 hours ago
Associate - Clinical Trials - Clinical Data
Indianapolis, IN
Full-time
Hybrid
Mid Level
$65K/yr - $165K/yr
3+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The Associate - Clinical Trials - Clinical Data role is responsible for managing clinical data strategy, ensuring data quality and compliance, and collaborating with study partners to deliver clinical data management packages.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
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
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
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
Qualification
Required
Master's degree in a scientific discipline such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, or Computer Science OR Bachelor's degree discipline above, plus 3+ years of experience in clinical trials, data management, or related areas (e.g., statistics, data analytics, information technology, health outcomes)
Preferred
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
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
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-17
2026-01-17
Company data provided by crunchbase