Lilly Clinical Data Associate in Indianapolis, Indiana
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 35,000 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.
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.
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
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
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:
- Enrolled in a Master’s program in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences and graduate by August 2023
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.
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!