Associate/Sr Associate, Clinical Data - Nilex

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 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.

Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.

Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just

some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with

disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself

Purpose:

The Clinical Data Associate 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 stakeholders to define, implement, and deliver clinical data management packages.  The Clinical Data Associate is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs. 

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Data Management, Planning and Delivery

• Define Lilly business requirements for the study/program
• 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 to 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 and ensures the data flow design is aligned with the project hypothesis
• Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements
• Approve key deliverables (i.e. Data Quality Delivery Plan, Datalock Plan, Project Plan, database, and observed datasets)
• Drive data cleaning activities throughout study execution
• Define and approve data quality and submission deliverables.
• Coordinates data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables
• Knowledge of, and familiarity with clinical data standards and the mapping to protocol data
• Knowledge of ePRO/eCOA instruments and scales, and their use in clinical studies.
• Provide a high level of expertise in data management to support clinical studies.
• Support inspection readiness through engagement cross functionally and within data team
• Manage and Drive requests for copyrights and translations for study related documents
• Manage trial timelines for data deliverables (FPV to database lock)
• Coordinate/lead data management milestones for data transfers and database locks
• Drive build implementation for eCOA, ensure execution of eCOA deliverables (on time with high quality) and serve as eCOA primary point of contact (POC)

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 and support 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

Communication

• Acts as primary communication point for all data management activities
• Report out status of data management milestones and data quality
• Partner with external data vendors: understand specifications to import multiple types of data, work with technical groups to ensure timely loads of external data sets into the sponsor's database.
• Excellent written and verbal communication skills, including the ability to represent yourself and the department in front of stakeholders
• Partner with cross-functional team members to ensure trial success through robust oversight/review

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 the Data and Analytics organization.
• Work with partners to increase vendor/partner efficiencies
• Prepare recommendations for new or improved processes relating to clinical data management. 
• Ability to represent the department on cross-functional study teams and project teams.

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 effectively partner/influence a virtual team and drive a technical project to deliver results
• Proven 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 liaise effectively with study team members (i.e. Statistics, PK, Operations, Medical)
  • Strong therapeutic/scientific knowledge in the field of research
• Knowledge of medical terminology
• International travel may be required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

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