Job Title: Database Programming Lead – Clinical Data Management
Location: Bengaluru, India (Hybrid)
Experience Required: 8+ Years in Pharmaceutical Industry; 6+ Years in Clinical Database Design and Management
Job Type: Full-Time
Astellas Pharma Inc. is a global pharmaceutical leader committed to turning innovative science into medical solutions that improve patient outcomes worldwide. Operating in over 70 countries, Astellas focuses on developing therapies that address unmet medical needs while maintaining the highest standards of ethics, integrity, and regulatory compliance.
Astellas’ Global Capability Centres (GCCs), including Bengaluru, Poland, and Mexico, strategically enhance operational efficiency, innovation, and resilience across the pharmaceutical value chain. These centers enable global collaboration, streamline processes, and support scalable, data-driven solutions for clinical development.
The Database Programming Lead is a key role within Astellas’ Clinical Data Management team, responsible for designing, implementing, and maintaining Medidata Rave clinical databases and related systems used in Phase I–IV clinical trials. This role drives innovation, automation, and efficiency in database setup, configuration, and maintenance while ensuring compliance with regulatory guidelines and internal standards.
This position also leads initiatives to improve processes, templates, and system interfaces, providing technical expertise to project teams, vendors, and cross-functional stakeholders. The role ensures high-quality clinical data management and supports regulatory submissions globally.
Database Design & Management:
Lead programming activities for multiple clinical studies, adhering to established timelines, SOPs, and quality standards.
Design, develop, and test clinical databases, including eCRFs, edit checks, derivations, custom functions, folders, matrices, and data dictionaries.
Support database build activities, change requests, interface configuration, and migrations.
Technical Leadership & Support:
Provide study-level support, resolving complex technical issues, and mentoring junior team members.
Create, review, and approve technical specifications for data management systems.
Collaborate with CRO vendors to ensure compliance with Astellas and industry standards.
Oversee user access management via iMedidata & Cloud Administration.
Quality & Compliance:
Maintain coding dictionaries, including MedDRA and WHODrug.
Resolve data anomalies and quality issues.
Contribute to the development of training materials, process guides, and departmental documentation.
Ensure regulatory compliance in line with FDA, ICH-GCP, and other Health Authority guidelines.
Innovation & Process Improvement:
Identify opportunities for database automation and process standardization.
Lead evaluation or improvement projects for data management applications and system integrations.
Track and report on best practices, lessons learned, and operational efficiencies.
Bachelor’s degree in Computer Science, Information Systems, or a related field.
8+ years of experience in the pharmaceutical industry.
6+ years of hands-on experience in clinical database design and management, specifically with Medidata Rave and custom function programming.
Proficiency in database structures, programming languages, eCRF design, and data validation checks.
Strong knowledge of QC, UAT, platform testing, and creating/executing test scripts.
In-depth understanding of the Drug Development Process, SDLC, Computer Validation, and regulatory requirements.
Proven experience in leading database-related projects and vendor collaborations.
Strong verbal and written communication skills for global collaboration.
Knowledge of Visual Basic, SAS, or other object-oriented programming languages.
Familiarity with additional Medidata modules: CTMS, RTSM, TSDV, Coder, Lab Admin.
Understanding of relational databases and data capture standards (CDISC/CDASH).
Advanced skills in MS Office, data analysis, pivot tables, and reporting tools.
Experience managing multiple technical projects and providing training/mentorship.
Demonstrated ability to innovate and transform industry practices for greater efficiency.
This role is based in Astellas’ Bengaluru GCC, part of a global network that supports innovation, operational efficiency, and resilience across the pharmaceutical value chain. The GCC fosters collaboration across multiple regions and disciplines to deliver life-changing therapies. A hybrid work model is available in accordance with Astellas’ Responsible Flexibility Guidelines.
Lead high-impact clinical database initiatives for Phase I–IV trials.
Drive innovation, automation, and operational efficiency in clinical data management.
Collaborate globally with CROs, vendors, and cross-functional stakeholders.
Play a pivotal role in delivering regulatory-compliant, high-quality data for global submissions.
Equal Opportunity Employer: Astellas is committed to equality of opportunity, including for individuals with disabilities and protected veterans.
Apply Now to be part of Astellas’ clinical data innovation team in Bengaluru.
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