Manager, Clinical Systems
Job Locations: Bangalore or Chennai, India
Work Model: Office with Flex (Hybrid)
Job Type: Full-Time
Job Requisition ID: JR141668
Industry: Clinical Research / Clinical Technology / Clinical Data Management
The Manager, Clinical Systems is a senior-level leadership role responsible for overseeing the implementation, optimization, governance, and compliance of clinical technology platforms supporting global clinical trials. This position plays a critical role in ensuring clinical systems operate efficiently, maintain regulatory compliance, and uphold the highest standards of data integrity across clinical development programs.
This opportunity is ideal for experienced clinical systems professionals with strong leadership capabilities and a deep understanding of regulatory frameworks, clinical data ecosystems, and digital transformation in clinical research.
Role Overview
The Manager, Clinical Systems leads the strategic development and operational oversight of clinical trial technology platforms, including electronic data capture (EDC), clinical trial management systems (CTMS), safety systems, and related digital tools. The role ensures system alignment with clinical study objectives, regulatory expectations, and organizational quality standards.
This position requires close collaboration with Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, and IT teams to ensure seamless system integration and optimal performance.
Key Responsibilities
Lead the development, implementation, validation, and optimization of clinical systems supporting global trials
Ensure systems comply with ICH-GCP, 21 CFR Part 11, and other applicable global regulatory requirements
Oversee system configuration, user access governance, and data integrity controls
Collaborate with cross-functional stakeholders to gather system requirements aligned with study objectives
Monitor system performance metrics and implement continuous improvement initiatives
Drive process standardization and automation to improve operational efficiency
Provide training, mentorship, and support to teams using clinical systems
Manage vendor relationships and technology partners to ensure service quality and compliance
Support audit and inspection readiness by maintaining proper system documentation and validation records
Required Experience
Minimum 8–12 years of experience in clinical research, clinical systems management, or clinical technology leadership
Proven experience managing EDC, CTMS, eTMF, safety databases, or related clinical platforms
Strong understanding of computerized system validation (CSV) and regulatory compliance frameworks
Experience leading cross-functional teams and managing system implementation projects
Educational Qualifications
Bachelor’s or Master’s degree in Life Sciences, Information Technology, Clinical Research, Biotechnology, or related field
Advanced degree preferred
Core Competencies and Skills
Deep knowledge of clinical trial lifecycle and data management processes
Strong expertise in clinical technology platforms and system optimization
Leadership and team management capabilities in a matrix environment
Excellent stakeholder communication and vendor management skills
Strategic thinking with a focus on digital innovation and operational excellence
Strong analytical skills with a data integrity mindset
Proficiency in regulatory frameworks impacting clinical systems
Strategic Impact of the Role
The Manager, Clinical Systems directly contributes to improving trial efficiency, ensuring regulatory compliance, safeguarding patient data, and enabling high-quality clinical outcomes. Effective system leadership supports faster study timelines, enhanced reporting accuracy, and inspection readiness across global programs.
Why Apply Through ThePharmaDaily.com
ThePharmaDaily.com connects clinical research and life sciences professionals with leading global CROs, pharmaceutical companies, and biotech innovators. If you have expertise in clinical systems governance, regulatory compliance, and digital clinical operations, this role offers a strong pathway into technology-driven clinical leadership.
Apply now to advance your career in Clinical Systems Management and Global Clinical Technology Leadership.
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