Are you ready for an exciting and meaningful career? Do you love working with data? The Data Sciences group at Lilly is looking to grow and add a Clinical Data Associate to its team. As part of the Clinical Data team you will be responsible for trial level clinical data strategy including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation. Do you have an in-depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards? We could use your skills. In this role you will collaborate with the Design Hub and key study partners to define, implement, and deliver clinical data management packages. You will provide trial leadership and own the processes 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 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.
- 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 craft 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.)
- 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 Clinical Labs and Data Sciences organization.
- Work with partners to increase vendor/partner efficiencies
- Asset Protection
- Understand the confidential nature of company information and take 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
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.
- Bachelor’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy or relevant field
- 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.
- Willingness to work in Indianapolis Corporate Center.
- 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.
- 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 or Business
- Experience with the following:
- Articulating the flow of data (structure and format) from patient to analysis and apply 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 field of research
- Society of Clinical Data Management certification
- Project management experience
- Vendor management experience
- Familiarity with clinical data tools and technologies
- Technical knowledge to develop requirements and/or study/project deliverables (i.e. SAS, Oracle, programming, analytical tools)
- Experience in forms design and layout
- Understanding and experience in using data standards
- Experience with crafting and handling of eCOA data
- Knowledge of medical terminology
- Domestic and International travel may be required