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Senior Database Designer - Job Opportunity at Sanofi EU

Hyderabad, India
Full-time
Senior
Posted: August 11, 2025
On-site
USD 45,000 - 65,000 per year based on Hyderabad market rates for senior-level clinical database design positions in multinational pharmaceutical companies, with potential for additional performance bonuses and stock options typical of global biopharma organizations

Benefits

Comprehensive high-quality healthcare coverage with prevention and wellness programs providing superior medical security compared to standard market offerings
Generous 14+ weeks gender-neutral parental leave significantly exceeding industry standards and demonstrating progressive family support policies
Thoughtfully designed rewards package with performance recognition systems that amplify career impact beyond basic compensation
International career mobility opportunities enabling global experience and cross-cultural professional development
Access to innovative biopharma environment with cutting-edge therapeutic area exposure across multiple disease areas

Key Responsibilities

Lead strategic clinical database architecture and eCRF design for global pharmaceutical trials, directly impacting drug development timelines and regulatory compliance across multiple therapeutic areas
Drive technical excellence in database post-production maintenance including complex impact assessments and seamless migration processes that ensure uninterrupted clinical trial operations
Orchestrate comprehensive project management through study setup Gantt Charts and timeline optimization, ensuring critical path adherence for multi-million dollar clinical programs
Architect and implement sophisticated Sanofi-specific technical solutions interfacing with enterprise clinical data management systems, enhancing operational efficiency and data integrity
Provide strategic technical leadership through development of user guides, detailed specifications, and best practices that standardize organizational clinical database operations
Drive innovation through analysis of emerging customer requirements and development of forward-thinking technical solution strategies that position the organization for future clinical trial evolution

Requirements

Education

Bachelor or Master of Science degree or above, preferably in a life science or mathematics-related area (e.g., Pharmaceutical, medical, or mathematics, computer science or similar technical fields)

Experience

Experience in clinical database design and maintenance are required and he/she can lead database design and maintenance for complex trials independently. In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred

Required Skills

Advanced project management skill Advanced collaboration and communication skill Outstanding capability of independent thinking and delivery of accurate outcomes Meeting management skill such as organize meeting and discussion Crystal clear logical thinking Advanced expertise in Clinical Data Management Systems (e.g. Medidata Rave, etc.) Advanced expertise in database structure and database administration Advanced expertise in C# programming and query language such as SQL Knowledge of industry standards and practices (e.g. CDISC especially CDASH and SDTM) Strong knowledge of current regulatory guidelines, and GCP practices regarding Data Management Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus Strong English skills (verbal and written), ability to exchange fluently in a global environment
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented digital transformation with increased adoption of decentralized clinical trials (DCT) and AI-based automation, driving demand for database designers who can architect flexible, cloud-native solutions that support remote patient monitoring and real-time data integration across multiple geographic locations. Regulatory agencies are implementing stricter data integrity requirements and real-time submission expectations, necessitating database designers who possess deep expertise in CDISC standards, particularly CDASH and SDTM, while maintaining compliance with evolving GCP guidelines and emerging regulatory frameworks. The shift toward master protocols and adaptive trial designs is revolutionizing clinical development, requiring database professionals who can design dynamic, modular database architectures that support multiple indications, seamless protocol amendments, and complex randomization schemas without compromising data quality or regulatory compliance.

Role Significance

Typically manages 2-4 direct reports or project team members while collaborating with cross-functional teams of 8-12 professionals including biostatisticians, clinical programmers, data managers, and regulatory affairs specialists
Senior individual contributor role with significant technical leadership responsibilities, serving as the primary database expert for multiple global clinical trials while mentoring junior team members and driving technical standards across the organization

Key Projects

Multi-phase global clinical trials spanning Phase I-III with complex adaptive designs and multiple treatment arms Enterprise-wide clinical data management system implementations and upgrades affecting hundreds of concurrent studies Regulatory submission database preparations for FDA, EMA, and other international health authorities requiring pristine data quality and comprehensive audit trails

Success Factors

Deep technical mastery of enterprise clinical data management platforms combined with pharmaceutical domain expertise that enables seamless translation of complex protocol requirements into robust, scalable database architectures that support both current needs and future protocol amendments. Exceptional project management capabilities with proven ability to manage multiple concurrent global clinical trials under tight regulatory timelines while maintaining unwavering attention to data quality, regulatory compliance, and cross-functional stakeholder satisfaction. Strong collaborative leadership skills that enable effective communication with diverse international teams, regulatory bodies, and external vendors while driving consensus on technical solutions that balance innovation with regulatory conservatism and operational feasibility.

Market Demand

High demand driven by accelerating clinical trial digitization, increasing regulatory complexity, and shortage of professionals with combined technical database expertise and deep pharmaceutical domain knowledge

Important Skills

Critical Skills

Advanced expertise in Medidata Rave represents the gold standard for clinical data management systems used by virtually all major pharmaceutical companies, making this skill essential for career advancement and directly applicable to complex global clinical trials requiring sophisticated database architectures and regulatory compliance capabilities. Deep knowledge of CDISC standards, particularly CDASH and SDTM, is absolutely crucial as these represent the international regulatory standard for clinical data collection and submission, with regulatory agencies increasingly requiring CDISC-compliant submissions and real-time data transparency. C# programming and SQL query expertise enables advanced database customization, automated data processing, and complex analytical capabilities that distinguish senior professionals from basic database users while supporting innovative clinical trial designs and regulatory submission requirements.

Beneficial Skills

Understanding of decentralized clinical trials (DCT) and AI-based automation positions professionals for the future of pharmaceutical development where remote patient monitoring, digital biomarkers, and machine learning algorithms will fundamentally transform clinical data collection and analysis methodologies. Advanced project management skills become increasingly valuable as clinical trials grow in complexity and international scope, requiring coordination of multiple vendors, regulatory bodies, and internal stakeholders across different time zones and regulatory jurisdictions. Strong regulatory knowledge of GCP practices and evolving FDA/EMA guidelines provides competitive advantage in an environment where regulatory requirements are becoming more stringent and data integrity expectations continue to escalate.

Unique Aspects

Opportunity to work on cutting-edge therapeutic areas including rare diseases, oncology, and immunology where Sanofi maintains global leadership positions and breakthrough pipeline assets
Direct exposure to advanced clinical trial methodologies including decentralized trials, master protocols, and AI-driven automation technologies that represent the future of pharmaceutical development
Integration with Sanofi's proprietary Safety Gateway system and other enterprise platforms providing unique technical experience not available at smaller pharmaceutical companies
Access to global mentorship and career development programs with potential for international assignments and cross-functional role transitions within a Fortune 500 pharmaceutical organization

Career Growth

3-5 years to progress to management roles with expanded scope, or 2-3 years to advance to principal technical architect positions within the same organization

Potential Next Roles

Clinical Data Management Lead overseeing entire therapeutic area portfolios Principal Database Architect designing enterprise-wide clinical data platforms Clinical Operations Manager with P&L responsibility for regional clinical development programs Regulatory Affairs Director focusing on data integrity and submission strategies

Company Overview

Sanofi EU

Sanofi stands as one of the world's largest pharmaceutical companies with a diversified portfolio spanning vaccines, rare diseases, oncology, immunology, and consumer healthcare, generating over €40 billion in annual revenue while maintaining significant investment in R&D innovation and digital transformation initiatives.

Global pharmaceutical leader ranked among the top 5 worldwide by revenue, with strong market presence in both developed and emerging markets, maintaining competitive advantage through robust pipeline development, strategic acquisitions, and comprehensive therapeutic area coverage.
The Hyderabad hub represents a critical component of Sanofi's global clinical development infrastructure, serving as a key center for clinical data management, biostatistics, and regulatory affairs support for worldwide clinical programs while leveraging India's strong technical talent pool and cost advantages.
International collaborative environment emphasizing scientific excellence, regulatory compliance, and patient-centric innovation, with strong emphasis on professional development, cross-cultural collaboration, and work-life balance supported by comprehensive benefits and career mobility programs.
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