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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.

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.

Portfolio Delivery

Program and test data collection systems for a trial or set of trials within a program using data standards libraryEnsure data collection systems are delivered accurately, efficiently and in alignment with study objectivesProvide 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 solutionsEnable metrics reporting of study development timelines and pre and post production changes to databasePartner with Clinical Data Management Associate to deliver study database per business need and before first patient visitComply with data standard decisions and strategies for a study and/or programUtilize therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial dataEffectively 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 effortRepresent Data and Analytics processes in cross-functional initiativesActively participate in shared learning across Data and Analytics organizationWork to Increase re-usability of forms and edits by improving the initial designWork to reduce post production changes change control process

Minimum Qualification Requirements:

6 to 8 years database programming and system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectorsBachelor’s degree in computer science, engineering, medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, PharmacyJob located in Bangalore, India

Other Information/Additional Preferences:

Masters degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy, BusinessExperience with the following:Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutionsDeciding the technology platform (system/database) for data acquisition and aggregationUtilization 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 researchSociety of Clinical Data Management certificationProject management experienceVendor management experienceFamiliarity with clinical data tools and technologiesUnderstanding and experience in using data standardsExperience with designing and handling of eCOA dataKnowledge of medical terminology

Domestic and International travel may be required

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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.

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