Principal Study Build Programmer

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.

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.

Continually seek and implement means of improving processes to reduce study build cycle time and decrease work effort.

Represent Data and Analytics processes in cross-functional initiatives.

Actively participate in shared learning across Data and Analytics organization.

Work to Increase re-usability of forms and edits by improving the initial design.

Work to reduce post production changes change control process.

Masters degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy, Business.

Experience with the following: Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions. Deciding the technology platform (system/database) for data acquisition and aggregation. Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical). Strong therapeutic/scientific knowledge in the field of research.

Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions.

Deciding the technology platform (system/database) for data acquisition and aggregation.

Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical).

Strong therapeutic/scientific knowledge in the field of research.

Society of Clinical Data Management certification.

Project management experience.

Vendor management experience.

Familiarity with clinical data tools and technologies.

Understanding and experience in using data standards.

Experience with designing and handling of eCOA data.

Knowledge of medical terminology.

Domestic and International travel may be required.

At Lilly, caring is not only what we do for patients. It is how we work. We believe the people who dedicate themselves to making medicines better deserve an environment that makes their lives better too, one where they are supported, respected, and given the space to do their best work. This is not just a policy. It is who we are.

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.