Sr. Executive – Clinical Database Programmer
Location: Gurgaon, India
Department: Clinical Data Management / Global Drug Development (GDO)
Employment Type: Full-Time
Company: Sun Pharmaceutical Industries Ltd.
Geographic Scope: Global
Job Summary
The Sr. Executive – Clinical Database Programmer is responsible for the design, development, validation, implementation, and maintenance of clinical study databases that support global clinical research programs. The role ensures the delivery of high-quality clinical data systems that comply with study protocols, Data Management Plans (DMPs), SOPs, CDISC standards, and applicable regulatory requirements.
The incumbent will collaborate with Clinical Data Management, Biostatistics, Clinical Operations, Medical Affairs, Pharmacovigilance, Regulatory Affairs, and external vendors to support efficient clinical trial execution and accurate data collection, integration, review, and reporting.
Key Responsibilities
Clinical Database Development & Programming
Design, develop, validate, test, and deploy clinical study databases for global clinical trials.
Analyze study protocols and project requirements to determine database specifications.
Design electronic Case Report Forms (eCRFs) and data entry interfaces aligned with study requirements.
Configure data validation checks and quality control rules to ensure data integrity.
Maintain and update clinical databases throughout the study lifecycle.
Clinical Data Integration & Management
Support preparation, transfer, integration, and reconciliation of clinical data from internal and external sources.
Manage data imports and exports from:
Central Laboratories
ECG Vendors
Imaging Vendors
Pharmacovigilance Systems
External Data Providers
Ensure timely availability of study data for project teams and stakeholders.
Facilitate seamless integration of external data into clinical databases.
Data Review & Reporting Support
Support setup and maintenance of data review and reporting tools.
Generate clinical data outputs and reports for:
Clinical Operations
Medical Affairs
Pharmacovigilance
Regulatory Affairs
Biostatistics
SAS Programming Teams
Ensure accurate and timely delivery of study data and reports.
Data Quality & Compliance
Implement and maintain data quality rules and edit checks.
Ensure compliance with:
Study Protocols
Data Management Plans (DMPs)
Standard Operating Procedures (SOPs)
CDISC Standards
Regulatory Requirements
Good Clinical Practice (GCP)
Conduct database validation and quality control activities.
Ensure high-quality deliverables throughout study execution.
Stakeholder & Vendor Management
Collaborate with internal project teams and external vendors.
Coordinate data exchange activities with:
Central Laboratories
ECG Providers
Imaging Vendors
Independent Data Monitoring Committees (IDMCs)
Safety Review Boards
Provide technical support and guidance to stakeholders regarding database functionality and data management processes.
Technical Support & Issue Resolution
Provide day-to-day support to clinical project teams.
Troubleshoot database and programming-related issues.
Ensure efficient system performance and data processing activities.
Communicate project status, risks, and technical issues to Clinical Data Management leadership.
Process Improvement & Innovation
Identify opportunities to improve data management and database programming processes.
Contribute to development and enhancement of standard operating procedures and programming standards.
Support automation, standardization, and process optimization initiatives.
Evaluate emerging technologies and tools to improve efficiency and quality.
Standards & Metadata Management
Support development and maintenance of:
Standard CRF Libraries
eCRF Libraries
Data Quality Rules
Standard Data Structures
Controlled Terminology
Code Lists
Medical Dictionaries
Ensure alignment with CDISC and industry best practices.
Training & Mentorship
Provide technical guidance and support to junior team members.
Assist in work delegation and project coordination.
Support training initiatives within the Clinical Data Management function.
Share best practices and promote continuous learning.
Educational Qualifications
Required
Bachelor’s Degree in:
Life Sciences
Nursing
Computer Science
Information Technology
Pharmacy
Biotechnology
Related Scientific Discipline
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Canada |Quebec :
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