Senior Associate - Clinical Study Build Programmer

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.

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary:

The Clinical Study Build Programmer is responsible for programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in depth understanding of data technology, data flow, data standards, database programming, normalization and testing. The Clinical Study Build Programmer will collaborate with Data and Analytics colleagues such as the CRF Standards Lead, Clinical Data Manager and other key stakeholders to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.

The ideal candidate will have varied experience in electronic data collection technologies, such as Veeva EDC, Medidata Rave, and Oracle InForm, etc., as well as a sufficient knowledge of industry clinical data standards, the management of CRF library collections, developing CRFs, dynamics and rules, and the integration of third-party data. project management of study deliverables and milestones.  The individual will be a self-starter with excellent leadership skills, strong focus on innovation, collaboration, and most importantly, application programming and tools as a representative of data and analytics processes across functional initiatives.

Responsibilities:

• Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
• Ensure data collection systems and data warehouse mappings 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)
• Contribute to the quality of the data management clinical database programming deliverables including specification development, eCRF development, edit checks programming, and Quality Testing.
• Serve as a subject matter expert in the use of EDC platforms and their suite of products including Studio/Designer, EDC, Local Lab Module, Coder, Data Extract and Reporting, among others. 
• Increase speed, accuracy, and consistency in the development of systems solutions
• Enable metrics reporting of study development timelines and pre and postproduction changes to database
• Partner with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Management Associate to deliver study database per business need and before first patient visit
• Comply with and influence data standard decisions and strategies for a study and/or program
• Provide oversight, technical support, and guidance to the study teams in the efficient use of the EDC product suite in the study planning, execution, and close out activities of clinical studies.
• Proactively identifies potential technical and operational issues/risks and recommends/ implements solutions.
• Perform all other tasks and activities as requested.

Basic Requirements:

• Bachelor’s degree preferred.
• Minimum 3 years’ experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors.
• Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
• Knowledge of industry standard clinical technologies including CTMS, EDC (Veeva CDMS preferred, Rave, InForm), eCOA, IxRS, Clinical Data Repositories, etc.
• Knowledge of CDISC and CDASH standards/standard terminology

Additional Preferences:

• Ability to work independently as well as in a team environment.
• Minimum 2 years’ oncology experience preferred.
• Project and Vendor management experience
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced