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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 Clinical Data Associate, Clinical Data Manager 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 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)

• Support submission, inspection and regulatory response activities

• Lead cross Business Unit/Therapeutic Area projects or programs with high complexity

• Develops and tests new ideas and/or applies innovative solutions that create value to the portfolio

Project Management

• 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

• 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

• Integrates cross-functional and/or external information and applies technical knowledge to data-driven decision making

Enterprise Leadership

• Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis

• 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 postproduction changes change control process

• Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization

• Interacts with regulators, business partners and outside stakeholders on business issues

• Thinks with end to end in mind consistently managing risk to minimize impact on delivery

• Builds a diverse cross-functional and internal/external network to understand how different disciplines and approaches contribute to research and development

• Focuses on defining database solutions and timelines in support of advancing the portfolio

Minimum Qualification Requirements:

• Master’s degree (or bachelor’s degree with equivalent experience in lieu of Masters) including 3-5 years clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors

Additional Preferences:

• Proficient experience using commercial clinical data management systems and/or EDC products (Veeva CDMS and Rave preferred)

• Quick learner to new trends in technology

• Excellent leadership, communication (written and oral) and interpersonal skills.

• Demonstrated leadership in professional setting

• Demonstrated teamwork and collaboration in a professional setting

• Domestic and International travel may be required

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

• 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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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