Job ID: #26-POS00085519M
Location: Bengaluru, India
Employment Type: Full-time
Company: Astellas Pharma Global Capability Center (GCC)
Astellas Pharma’s Global Capability Centers (GCCs) serve as strategic hubs that centralize critical capabilities across the pharmaceutical value chain. With GCCs in India, Poland, and Mexico, Astellas enhances operational efficiency, resilience, and innovation while enabling rapid response to evolving global healthcare demands.
Guided by shared values and a strong commitment to patient-centric innovation, Astellas GCCs play a pivotal role in delivering sustainable growth and transforming cutting-edge science into tangible value for patients worldwide.
Astellas is seeking a highly experienced Database Programming Manager to lead the design, development, and maintenance of clinical trial databases supporting Phase I–IV studies. This role requires deep expertise in Medidata Rave EDC, clinical database architecture, and cross-functional collaboration across clinical, data management, and programming teams.
The position plays a critical leadership role in translating protocol and functional requirements into scalable, compliant, and high-quality technical database specifications while driving innovation, automation, and continuous improvement across data management systems.
Lead and manage clinical database setup activities for multiple concurrent studies of varying complexity
Translate functional and protocol requirements into detailed technical specifications for database programmers
Design, develop, test, and maintain clinical databases including eCRFs, forms, folders, matrices, edit checks, derivations, custom functions, and dictionaries
Ensure technical feasibility, scalability, compliance, and alignment with organizational standards
Oversee the development and maintenance of 18–20 clinical studies annually
Act as a key liaison between Database Programmers, Data Managers, Clinical Teams, and CRO partners
Lead technical discussions, screen review sessions, and specification walkthroughs prior to database build
Provide expert-level technical guidance and mentorship to junior team members
Present complex technical concepts clearly to diverse global stakeholders
Ensure high-quality documentation, traceability, and compliance across systems and studies
Support QC, UAT, platform testing, and validation activities including CRF, data flow, and edit check UAT
Identify metadata anomalies, quality risks, and implement corrective solutions
Drive process optimization, standardization, and automation to reduce study setup timelines
Contribute to the development of standards, templates, training materials, and process documentation
Support evaluation and improvement initiatives for data management tools and system integrations
Oversee CRO-managed data management systems, ensuring adherence to Astellas and industry best practices
Proactively identify, communicate, and mitigate risks related to database design and implementation
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
Proven expertise with Medidata Rave EDC in Phase I–IV clinical trials
Demonstrated experience managing complex, multi-region, multi-cohort clinical studies
Bachelor’s degree in Computer Science, Life Sciences, or a related field
Strong expertise in protocol interpretation and translation into eCRF and database specifications
Advanced knowledge of clinical trial design elements including arms, cohorts, visits, endpoints, and SOA
Expertise in eCRF design, DVS creation, edit checks, derivations, and custom functions
Proficiency in CRF UAT, Data Flow UAT, Edit Check UAT, and test case development
Strong understanding of FDA regulations, ICH-GCP, SDLC, CSV, and drug development processes
Excellent verbal, written, organizational, and stakeholder management skills
Experience with additional Medidata modules such as CTMS, RTSM, TSDV, Coder, and Lab Admin
Knowledge of CDISC/CDASH standards and relational database concepts
Strong proficiency in MS Excel (advanced), Word, PowerPoint, and Outlook
Experience integrating external data sources (IRT/RTSM, labs, imaging, eCOA, safety systems)
Exposure to Agile methodologies in clinical database development
Experience creating CRF Completion Instructions (CCI) documentation
Ability to mentor teams, lead best-practice discussions, and drive innovation in data management
Strong analytical, problem-solving, and risk assessment skills
This role offers a unique opportunity to influence global clinical trial data strategies within a world-class pharmaceutical organization. You will work at the intersection of clinical science, technology, and innovation, contributing directly to high-impact studies that improve patient outcomes worldwide.
Database Programming Manager Jobs India, Medidata Rave Jobs Bengaluru, Clinical Database Manager India, EDC Programming Pharma Jobs, Global Capability Center Pharma Careers, Clinical Data Management Leadership Roles
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