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:
- 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.
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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
Eli Lilly and Company
Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War.