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 39,000 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.
The Data Sciences and Solutions department is responsible for global consistency of medical data; database structure, content and meaning, acquisition, storage, retrieval, interchange and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards.
The Clinical Data Leader role is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs. The broad applications of this role are:
Provides the single point of requirements definition, strategy communication, and deliverable acceptance to the vendors executing delivery of clinical data management
Provides single point of accountability and deliverable ownership for all aspects of clinical data management for analysis.
Acts as the primary contact to the study team and program team members for data science and data solution application.
Acts as a primary contact within the Data Sciences & Solutions organization for all data issues related to assigned trials
Applies specialized therapeutic knowledge and data management discipline knowledge to ensure database deliverables are consistent, accurate, adherent to the data strategy, and deliver the clinical, biostatistical, and business demands of the team.
Deliverable Ownership and Vendor Management (50%)
Define Lilly business requirements for the study/program for vendors to deliver
Ensure that data management deliverables are delivered to scope, cost, and time objectives
Execute 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 deliverables (i.e. Data Quality Delivery Plan, Datalock Plan, Project Plan, database, and observed datasets)
Define and approve data quality and submission deliverables
Trial Leadership (35%)
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
Utilize 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
Process Improvement (10%)
Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
Represent Data Sciences processes in cross-functional initiatives.
Actively participate in shared learning across Data Sciences and Solutions
Work with partners to increase vendor/partner efficiencies.
Asset Protection (5%)
Understand the confidential nature of company information and takes necessary steps to ensure its protection. This includes understanding various aspects of Privacy as it relates to the data managed within Data Sciences and Solutions.
Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties
Accept obligation to Lilly for compliance to the integrity of the company
Complete readings of any policy/procedure updates including global medical, Data Sciences and Solutions, and local policies and procedures
Bachelor s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
3 years Data Management experience or 5 years experience in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.)
Masters degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy, Business
Experience with the following:
Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
Deciding the technology platform (system/database) for data acquisition and aggregation
Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)
Strong therapeutic/scientific knowledge in the Oncology field of research
Project management experience
Vendor management experience
Virtual team environment experience
Familiarity with clinical data tools and technologies
Understanding and experience in using data standards
Knowledge of medical terminology
Domestic and International travel may be required
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.