Principal Study Build Programmer

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  About Lilly At Lilly, everything we do starts with patients. We unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, our global team of over 50,000 employees work with urgency and purpose to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. We bring our best to this work because people depend on it. If you're driven by purpose and determined to make a meaningful difference for patients, we invite you to bring your skill and your commitment to Lilly. About Lilly Research Labs, Bengaluru At Lilly in Bengaluru, the research function works directly alongside Lilly's global teams to advance the science behind tomorrow's medicines. Whether through product research and development, computational modelling, data-driven experimentation, or the intelligence that shapes Lilly's external innovation strategy, the work here contributes to the pipeline that will determine which life-changing medicines reach patients across the globe.

Purpose The Clinical Study Build Associate is responsible for programming and testing clinical trial data collection databases. This requires an in depth understanding of data technology, data flow, and data standards. The Clinical Study Build Associate will collaborate with the Clinical Data Management Associate, Clinical Data Associate and other key stakeholders to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.

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. Portfolio Delivery Program and test data collection systems for a trial or set of trials within a program using data standards library. Ensure data collection systems are delivered accurately, efficiently and in alignment with study objectives. Provide insights into study level deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets). Support submission, inspection and regulatory response activities. Project Management Increase speed, accuracy, and consistency in the development of systems solutions. Enable metrics reporting of study development timelines and pre and post production changes to database. Partner with Clinical Data Management Associate to deliver study database per business need and before first patient visit. Comply with data standard decisions and strategies for a study and/or program. Utilize therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data. Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables. Enterprise Leadership Continually seek and implement means of improving processes to reduce study build cycle time and decrease work effort. Represent Data and Analytics