Manager, Database Developer – Clinical Database Management
Location: Chennai, India
Work Model: Hybrid
Employment Type: Full-Time
Company: Pfizer
About the Organization
Pfizer is a global biopharmaceutical leader committed to discovering, developing, and delivering innovative medicines and vaccines. Within its Clinical Development & Operations (CD&O) organization, the Clinical Data Sciences (CDS) group plays a critical role in ensuring high-quality clinical data management, regulatory compliance, and data-driven decision-making across the drug development lifecycle.
Role Overview
The Manager, Database Developer – Clinical Database Management is responsible for providing project management leadership and technical expertise in clinical database design, development, and lifecycle management.
As a key contributor within Clinical Data Sciences, this role oversees database build processes, change control management, and application of global standards to ensure clinical data integrity across assigned therapeutic areas. The position collaborates closely with Clinical Data Scientists, cross-functional study teams, and technical stakeholders to deliver high-quality, regulatory-compliant clinical data systems.
Key Responsibilities
Clinical Database Development & Oversight
Lead the design, development, validation, and maintenance of clinical databases and related data capture technologies.
Oversee database build lifecycle and change control processes to ensure data integrity and compliance with company standards.
Perform impact analysis for proposed changes to tools, systems, and processes, communicating effectively to technical and non-technical stakeholders.
Serve as a Subject Matter Expert (SME) for database build within assigned therapy areas.
Project Management & Leadership
Develop and implement database development project plans aligned with study timelines and data review plans.
Proactively identify risks and implement mitigation strategies to ensure timely database delivery.
Lead operational work teams to support departmental goals and clinical trial milestones.
Mentor junior team members and support cross-functional collaboration across CDS functions.
Process Excellence & Innovation
Ensure compliance with SOPs, regulatory requirements, and global data standards.
Drive process improvements and participate in enterprise-level CDS initiatives.
Develop innovative concepts to enhance database management processes and tools.
Ensure seamless collaboration between Database Management (DBM) and Clinical Data Scientist functions.
Regulatory & Standards Compliance
Support adherence to clinical data standards and regulatory submission requirements.
Participate in internal standards meetings and governance forums.
Assess change control impacts and implement mitigation plans for emerging risks.
Educational Qualification
Bachelor’s degree in Life Sciences, Computer Science, or related discipline.
Experience Required
Minimum 10 years of relevant project management experience in pharmaceutical, biotech, CRO, or regulatory environments.
Proven experience in clinical database build, Electronic Data Capture (EDC) systems, and data assimilation solutions.
Demonstrated leadership experience managing database development projects across clinical programs.
Technical Skills & Expertise
Strong knowledge of Electronic Data Capture (EDC) systems and Clinical Data Management Systems (CDMS).
Experience with relational databases such as Oracle InForm, Data Management Workbench, MS SQL Server, or MS Access.
Familiarity with data visualization tools such as Spotfire and J-Review.
Experience using MS Project or enterprise project management tools.
Understanding of clinical trial data reporting processes, including study reports and regulatory submissions.
Knowledge of CDISC standards and regulatory data requirements preferred.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
Core Competencies
Clinical Data Management & Database Development
Risk Assessment & Change Control Management
Cross-Functional Collaboration
Regulatory Compliance & Data Standards
Strategic Planning & Operational Execution
Communication & Stakeholder Management
Work Environment
This is a hybrid, office-based role requiring significant time working on computer-based clinical data systems, conducting presentations, and collaborating with global teams.
Why Apply?
This opportunity is ideal for experienced Clinical Database Management professionals seeking leadership exposure within global drug development programs. The role offers involvement in advanced clinical data technologies, regulatory submissions, and enterprise-level process innovation within a globally recognized pharmaceutical organization.
Explore more Clinical Data Management, Regulatory Affairs, Biostatistics, and Pharmaceutical leadership opportunities at ThePharmaDaily.com.
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