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.
The Clinical Data Associate is responsible for global consistency of medical data; 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, data archiving and data standards.
The purpose of the Associate/Sr. Associate Consultant – Clinical Data roles is to provide trial leadership and ownership for a particular trial, set of trials, or programs. The broad applications of this role are:
Provide the single point of requirements definitions, 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
Act as the primary contact to the study team and program team members for data science and data solutions applications.
Acts as a primary contact within the Data Sciences 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, statistical, and business demands of the team
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
Drives data flow design through consultation, review, and approval of vendor work. Ensures the data flow design is aligned with the project hypotheses
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 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 or 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 (MHLW. JPMA, FDA, ICH, GCP, PhPMA, Privacy knowledge, etc.) to deliverables
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 organization
Work with partners to increase vendor/partner efficiencies
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
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 local policies and procedures
Minimum Qualification Requirements:
Bachelor’s degree or equivalent experience
Minimum of 3 years experience in clinical data management and/or 5 year experience in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc, demonstrating the ability to
Articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
Decide the technology platform (system/database) for or data acquisition and aggregation
Clinical knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)
Strong therapeutic/scientific knowledge
Project management experience
Vendor management experience
Virtual team environment experience
Other Information/Additional Preferences:
Strong interpersonal and leadership skills
Excellent oral and written communication skills
Familiarity with clinical data tools and technologies
Technical knowledge to develop requirements and/or study/project deliverables (i.e. SAS, Oracle)
Experience in forms design and layout
Understanding and experience in using data standards
Knowledge of medical terminology
Process management expertise
Domestic and International travel may be required
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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).
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!