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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

Primary Responsibilities:

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

Project Management

  • 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

Process Improvement

  • 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

Asset Protection

  • 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:

  • SCDM certification

  • 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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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).

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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!

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