Position Title: Principal / Sr. Principal – Study Build Programmer
Job ID: R-91692
Category: Research & Development
Job Type: Full Time, Regular
Location: Bangalore, Karnataka, India
🌍 About Lilly
At Lilly, we unite caring with discovery to make life better for people worldwide. Headquartered in Indianapolis, Indiana, Lilly is a global healthcare leader committed to:
Discovering and delivering life-changing medicines
Improving disease understanding and management
Supporting communities through philanthropy and volunteerism
We encourage internal mobility and career growth, allowing employees to explore new roles within Lilly while leveraging existing skills and expertise.
🎯 Role Purpose
The Study Build Programmer – eDC is responsible for programming and testing clinical trial data collection databases and mapping/normalizing data into clinical data warehouses.
The role requires in-depth knowledge of:
Data technology and flow
Database programming and normalization
Clinical trial systems and standards
The Study Build Programmer collaborates with Clinical Data Associates, Clinical Data Managers, and other stakeholders to deliver standardized, innovative, and compliant data collection solutions for global clinical trials.
🧠 Key Responsibilities
1. Portfolio Delivery
Program and test data collection systems and repository mappings using data standards libraries.
Ensure accuracy, efficiency, and alignment with study objectives.
Provide insights into study-level deliverables (Data Management Plan, Project Plan, databases, datasets).
Support regulatory submissions, inspections, and responses.
Lead cross-BU/Therapeutic Area projects with high complexity.
Develop and implement innovative solutions that add value to the portfolio.
2. Project Management
Increase speed, accuracy, and consistency in study build development.
Enable metrics reporting for study development timelines and database changes.
Partner with Data and Analytics colleagues to deliver study databases before first patient visits.
Influence and comply with data standards and strategies.
Apply therapeutic knowledge and technology expertise for data collection.
Ensure compliance with regulatory and internal requirements (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy).
Integrate cross-functional and external information for data-driven decision-making.
3. Enterprise Leadership
Continuously improve processes to reduce study build cycle time and enhance data normalization.
Represent Data and Analytics processes in cross-functional initiatives.
Participate in shared learning across the Data and Analytics organization.
Increase reusability of forms and edits, and reduce postproduction changes.
Anticipate and resolve technical, operational, or business challenges.
Interact with regulators, business partners, and external stakeholders.
Manage risk to minimize impact on delivery.
🎓 Qualifications & Experience
Minimum Requirements
Master’s degree in Informatics, Analytics, Life Sciences, IT, Computer Science, or bachelor’s degree plus 3+ years experience in clinical data management, database programming, or system validation in pharma, biotech, CRO, or regulatory agency.
Quick learner with adaptability to new technologies.
Strong leadership, communication, and interpersonal skills.
Demonstrated teamwork and collaboration in professional settings.
Domestic and international travel may be required.
Preferred Skills
Expertise in data flow and structure from patient to analysis.
Ability to decide technology platforms for data acquisition and aggregation.
Strong therapeutic/scientific knowledge for effective study team collaboration.
Society of Clinical Data Management (SCDM) certification.
Experience in project and vendor management.
Familiarity with clinical data tools, data standards, and eCOA data.
Knowledge of medical terminology and clinical trial processes.
♿ Equal Opportunity & Accommodation
Lilly is committed to inclusive workforce practices for individuals with disabilities.
For accommodations during the application process, complete the Accommodation Request Form.
We uphold equal opportunity employment, without discrimination based on age, race, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, veteran status, or other legally protected characteristics.
🔖 #WeAreLilly
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