Clinical Data Associate

Eli Lilly and Company • Us, IN

20h • Onsite

About The Position

The Clinical Data Associate is accountable for end-to-end clinical data sciences delivery for a clinical study, including clinical database build, data acquisition, storage, retrieval, and exchange. The role requires an in-depth understanding of study design, data standards, protocols, data flows, systems, and processes for collecting and managing clinical study data. The associate represents the clinical data sciences function, collaborates with and manages study collaborators, and provides clinical data science leadership and ownership for a study, set of studies, or programs.

The position oversees clinical data management from study setup through trial execution and database lock. Responsibilities include monitoring sourcing providers, ensuring vendor performance and data flow, developing and maintaining study plans, driving data cleaning, and ensuring database deliverables are consistent and accurate. The associate supports inspection readiness, applies relevant regulatory and internal requirements, manages study-related document requests, and leads eCOA build implementation and delivery.

The associate manages clinical data deliverables against scope, cost, and timelines; coordinates data transfers and database locks; communicates status and data quality; partners with external data vendors and cross-functional teams; and drives process improvements, automation, and efficiency. The role is based onsite in Indianapolis, Indiana, and domestic and international travel may be required.

Requirements

• Master’s degree in a scientific or technical field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, or Computer Sciences; alternatively, a bachelor’s degree plus at least 3 years of experience in clinical data management or a closely intersecting area.
• Legally authorized to work in the United States.
• Willing and able to work onsite in Indianapolis, Indiana.
• Ability to effectively partner with and influence a virtual team and drive a technical project to positive results.
• Ability to lead the development of creative solutions to data-related clinical development challenges.
• Ability to balance multiple activities, prioritize, and manage ambiguity.
• Exemplary teamwork and interpersonal skills.
• Problem-solving ability, attention to detail, and results-oriented behavior in a fast-paced environment.
• Ability to communicate effectively in writing and verbally.
• Ability to partner with study team members across functions, including Statistics, PK, Operations, and Medical.
• Experience articulating data flow structure and format from study start-up to analysis and applying that knowledge to data solutions.
• Experience utilizing clinical or drug development knowledge and liaising effectively with study team members.
• Strong therapeutic or scientific knowledge in the research field.
• Knowledge of medical terminology.

Nice To Haves

• Society of Clinical Data Management certification.
• Working knowledge of programming languages and industry tools such as Tableau, PowerBI, Python, SAS, R, and Shiny for reporting, metrics, and visualizations.
• Working knowledge of P-SQL and T-SQL for database management systems.
• Passion for improving technological solutions using new technologies.

Responsibilities

• Oversee end-to-end clinical data management activities from study setup through trial execution and database lock, including project monitoring and quality oversight of sourcing providers.
• Ensure vendor performance and program-level data flow across niche vendors and data sources, including pharmacokinetics, immunogenicity, and biomarkers.
• Partner with the Clinical Data Strategist to ensure data flow design and data collection meet study protocol requirements.
• Develop and maintain the Data Management Plan throughout the study lifecycle and ensure it is followed.
• Drive data cleaning activities and use therapeutic knowledge and data-review technologies to ensure accurate, consistent database deliverables.
• Identify and drive implementation of post-production changes to the Clinical Database.
• Develop and maintain plans for key study deliverables, including the Data Quality Delivery Plan, Datalock Plan, and Project Plan.
• Provide expertise and consultation on data management processes, principles, and deliverables.
• Represent clinical data sciences in inspections and support inspection readiness within the function and across teams.
• Apply relevant internal, external, and regulatory requirements and expectations to data deliverables.
• Manage and drive copyright and translation requests for study-related documents.
• Drive eCOA build implementation, ensure eCOA deliverables are timely and high quality, and serve as the eCOA point of contact.
• Ensure clinical data science deliverables meet scope, cost, and time objectives.
• Manage clinical data deliverable timelines from first patient visit to database lock, and plan, coordinate, and communicate activities leading to database lock.
• Coordinate or lead data management milestones for data transfers and database locks.
• Manage deliverable scope through scenario planning and negotiation with study teams, considering cost and value.
• Manage risks that could affect study deliverables.
• Serve as the primary communication point for study-related data management activities and report milestone and data-quality status.
• Partner with external data vendors to understand specifications and coordinate timely loads of external datasets into the sponsor's database.
• Represent the Data and Analytics organization and influence team members to support data-driven decisions.
• Partner with cross-functional team members to support trial success through oversight and review.
• Seek and implement process improvements and automation to increase efficiency, reduce cycle times, and improve quality.
• Represent clinical data sciences processes in cross-functional initiatives and participate in shared learning across the Data and Analytics organization.
• Work with partners to improve vendor and partner efficiency and recommend improved clinical data management processes.

Benefits

• Company bonus eligibility, 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.
• Employee resource groups that provide support networks and are open to all employees.

What This Job Offers

• Job Type: Full-time