Database Programming Lead / Manager (Technical Designer)
Job ID: 25-POS00085519M
Location: Bengaluru, India
Employment Type: Full-time
Industry: Pharmaceuticals / Clinical Research / Life Sciences
About Astellas Global Capability Centers (GCCs)
Astellas Global Capability Centers (GCCs) are strategic hubs designed to centralize critical capabilities across the pharmaceutical value chain. With GCCs located in India, Poland, and Mexico, Astellas leverages global talent to enhance operational efficiency, innovation, and resilience.
These centers are integral to Astellas’ mission of transforming innovative science into meaningful value for patients worldwide, while supporting sustainable growth and strategic priorities.
Role Overview
Astellas is seeking an experienced Database Programming Lead / Manager (Technical Designer) to support global Phase I–IV clinical trials. This role is responsible for translating functional and clinical requirements into scalable, compliant technical database designs using Medidata Rave EDC.
The Technical Designer acts as a key liaison between Database Programmers, Data Management, Clinical, and CRO teams, ensuring high-quality database builds, adherence to standards, and continuous process improvement.
Key Responsibilities
Technical Leadership & Study Delivery
Lead end-to-end database design and study setup activities for 18–20 clinical studies annually
Design, develop, and test clinical databases, including eCRFs, edit checks, derivations, dictionaries, matrices, and custom functions
Translate protocol requirements into detailed technical specifications for database programmers
Ensure technical feasibility, scalability, and compliance with organizational and regulatory standards
Collaboration & Governance
Act as the primary technical interface between data management, clinical teams, programmers, and CRO vendors
Review and approve technical specifications, change requests, and database build documents
Oversee CRO-managed database activities, ensuring quality, timelines, and adherence to best practices
Support issue resolution, metadata anomalies, and quality investigations
Process Improvement & Innovation
Drive automation and standardization initiatives to reduce database setup timelines
Develop and enhance standards, templates, and process documentation
Contribute to training materials, technical guidelines, and departmental knowledge repositories
Mentor junior team members and provide expert-level technical guidance
Required Qualifications & Experience
Bachelor’s degree in Computer Science or a related discipline
Minimum 8 years of experience in the pharmaceutical or clinical research industry
At least 4 years of hands-on experience in clinical trial database design and management using Medidata Rave EDC
Proven expertise in protocol interpretation and eCRF specification development
Strong experience in Data Validation Specifications (DVS), UAT testing, QC, and platform validation
In-depth understanding of endpoints, Schedule of Activities (SOA), and safety data requirements
Excellent stakeholder communication and cross-functional collaboration skills
Preferred Qualifications
Experience with additional Medidata modules (CTMS, RTSM, TSDV, Coder, Lab Admin)
Knowledge of CDISC standards (CDASH, SDTM) and relational database structures
Experience with Agile methodologies in clinical research and database development
Strong understanding of FDA regulations, ICH-GCP, Computer Validation, and SDLC
Hands-on experience integrating external data sources (IRT, labs, imaging, eCOA, safety systems)
Ability to manage complex protocols with adaptive designs, multiple cohorts, and dynamic visit schedules
Experience creating CRF Completion Instructions (CCI) and validation checks
Key Skills
Clinical database architecture and technical design expertise
Strong analytical, problem-solving, and risk-assessment skills
Advanced proficiency in MS Office (Excel, PowerPoint, Word, Outlook)
Ability to manage multiple studies and competing priorities
Leadership, mentoring, and training capabilities
Excellent written and verbal communication skills
Why Join Astellas
Work on global, high-impact clinical trials
Be part of a future-focused GCC driving innovation and efficiency
Collaborate with cross-regional teams and industry experts
Opportunity to influence standards, automation, and best practices in data management
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