Principal Study Build Programmer (eDC)
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time (Regular)
Job ID: R-89839
Path/Level: R3
About Lilly
Lilly is a global healthcare leader with over 39,000 employees dedicated to discovering life-changing medicines, improving disease management, and supporting communities worldwide. Lilly believes in developing internal talent and encourages employees to explore new opportunities within the organization.
Role Overview
The Principal Study Build Programmer – eDC is responsible for programming, validating, and maintaining clinical data collection databases. The role involves designing eDC systems, mapping data into clinical data warehouses, ensuring compliance with global standards, and enabling efficient, accurate data capture for global clinical trials.
The programmer collaborates closely with Clinical Data Associates, Clinical Data Managers, and other Data & Analytics partners to ensure standardized, high-quality database builds.
Key Responsibilities
1. Portfolio Delivery
Program and test clinical trial data collection systems using standardized library components.
Ensure accurate and efficient delivery of eDC systems and data warehouse mappings aligned with study objectives.
Contribute to study-level deliverables such as:
Data Management Plan
Project Plan
Study database
Observed datasets
Support regulatory submissions, inspections, and responses.
Lead complex cross–Business Unit or Therapeutic Area projects.
Develop and apply innovative ideas that add value to the study portfolio.
2. Project Management
Improve speed, accuracy, and consistency in system development and data flows.
Enable metrics reporting for study development timelines and database changes.
Collaborate with Clinical Data Associates and Clinical Data Management to deliver the study database before first patient visit.
Ensure compliance with data standards, strategies, and internal/external regulatory expectations (ICH-GCP, FDA, MHRA, MQA, CSQ, PhRMA, privacy standards, etc.)
Use therapeutic area knowledge and deep understanding of clinical data collection technologies.
Integrate cross-functional inputs for strong data-driven decision-making.
3. Enterprise Leadership
Drive process improvements to:
Reduce study build cycle time
Minimize effort
Improve data normalization and integration
Represent Data & Analytics in cross-functional projects and initiatives.
Contribute to shared learning, best practices, and reusability across the organization.
Improve initial form design to reduce post-production changes.
Anticipate and resolve technical or operational challenges impacting Data & Analytics.
Interact with regulators, partners, and external stakeholders on key data issues.
Think end-to-end and manage risks effectively to ensure smooth clinical delivery.
Qualifications & Expectations
(Note: Original job description does not list specific qualifications, but senior technical/clinical data experience is expected for R3 roles.)
Typically expected for a Principal Programmer role:
Strong experience in eDC systems (e.g., Medidata Rave, Inform, Veeva, etc.).
Expertise in clinical data standards (CDISC, SDTM, CDASH).
Deep understanding of clinical research, data flows, and regulatory requirements.
Technical proficiency in database programming, data mapping, normalization, and testing.
Strong leadership, problem-solving, and communication skills.
Inclusivity Statement
Lilly is committed to equal opportunity, disability accommodation during hiring, and a workplace free of discrimination based on age, gender, race, religion, sexual orientation, identity, nationality, veteran status, or disability.
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