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 cop