Manager - Clinical Systems & Trial Technology Operations

Why This Role Matters

Clinical trials today are driven by technology. From data capture and reporting to regulatory documentation and analytics, clinical systems form the backbone of modern trial execution. When these systems function efficiently, studies run smoothly, data integrity is maintained, and regulatory expectations are met. When they fail, timelines slip, compliance risks increase, and patient safety may be compromised.
The Manager – Clinical Systems plays a strategic and operational leadership role in ensuring that clinical technology platforms are optimized, compliant, and aligned with study objectives. At ICON plc, this position directly supports the delivery of high-quality clinical trials by overseeing system implementation, performance monitoring, and continuous improvement initiatives. The role bridges clinical operations and technology, ensuring that innovation translates into measurable efficiency and compliance outcomes.

Job Description

The Manager, Clinical Systems (Bangalore, Office-based) is responsible for leading the implementation, maintenance, and optimization of clinical systems that support global clinical trials. This role oversees system configuration, process alignment, performance monitoring, and user enablement to ensure seamless trial management.
The position requires strong leadership capabilities, technical proficiency in clinical systems, regulatory awareness, and the ability to collaborate cross-functionally. The Manager ensures systems are compliant with global standards while enhancing usability, efficiency, and data accuracy.

Key Features of the Role

• Leadership position within Clinical Technology Operations
• Strategic oversight of clinical systems lifecycle
• Cross-functional stakeholder engagement
• Compliance-focused and audit-ready environment
• Opportunity to drive innovation and system optimization
• Exposure to global clinical development programs
• Career pathway toward senior clinical technology leadership roles

Responsibilities

• Lead the development, implementation, and optimization of clinical systems supporting trial execution.
• Oversee system configuration to ensure alignment with study protocols and operational requirements.
• Collaborate with Clinical Operations, Data Management, Regulatory, and IT teams to gather and define system requirements.
• Ensure systems comply with regulatory standards including ICH-GCP and applicable global guidelines.
• Monitor system performance through dashboards, KPIs, and periodic assessments.
• Identify opportunities for process enhancement and implement efficiency improvements.
• Ensure data integrity, traceability, and security within clinical platforms.
• Provide training and guidance to users, fostering accountability and system proficiency.
• Manage vendor relationships and technology partners to support system initiatives.
• Address system-related risks proactively and implement mitigation strategies.
• Support inspection readiness activities related to clinical systems documentation and validation.
• Drive continuous improvement initiatives within clinical technology frameworks.

Required Qualifications

• Strong knowledge of clinical trial systems and technology infrastructure.
• Understanding of regulatory frameworks impacting clinical systems.
• Leadership capability with experience managing or mentoring teams.
• Ability to align technology solutions with operational trial objectives.
• Strong analytical mindset and problem-solving skills.
• Excellent stakeholder management and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.

Educational Requirements

• Advanced degree in Life Sciences, Information Technology, Clinical Research, or a related discipline.
• Bachelor’s degree with significant relevant experience may also be considered.
• Certifications in clinical systems, data management, or project management are advantageous.

Experience and Skills

• Extensive experience managing clinical systems or related technology platforms within clinical research.
• Strong understanding of electronic data capture (EDC), CTMS, eTMF, and related clinical applications.
• Experience overseeing system implementation or upgrades.
• Knowledge of system validation processes and regulatory compliance requirements.
• Demonstrated leadership experience in dynamic and cross-functional environments.
• Proficiency in clinical data management tools and reporting systems.
• Strong understanding of user experience optimization and workflow design.
• Experience collaborating with technology vendors and internal IT teams.
• Ability to analyze system performance metrics and implement data-driven improvements.

Salary Insights

Compensation is competitive and aligned with senior-level clinical technology management roles within global CROs. Salary may vary based on experience, leadership scope, and system expertise.

In addition to base compensation, employees at ICON plc may receive:• Comprehensive health insurance options
• Retirement planning and long-term savings programs
• Performance-based incentives
• Annual leave entitlements
• Global Employee Assistance Programme (LifeWorks)
• Life assurance coverage
• Flexible benefit schemes including wellness and lifestyle options

Company Overview

ICON plc is a leading healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies worldwide. With operations across multiple continents, ICON accelerates the development of innovative therapies that improve patient outcomes.
The organization emphasizes diversity, inclusion, and professional development. Employees benefit from global exposure, structured learning opportunities, and leadership development pathways. ICON’s culture encourages collaboration, accountability, and continuous improvement.
Inclusion and belonging are fundamental to ICON’s values. The company is committed to providing an accessible and equitable environment for all employees and candidates.

FAQs

1. Is this a technical IT role or a clinical operations role?
It is a hybrid leadership role that bridges clinical operations and technology management.

2. Does this position require direct system configuration experience?
Yes, experience with system implementation and optimization is highly valuable.

3. Is vendor management part of the role?
Yes, collaboration with technology partners and vendors is a key responsibility.

4. Does the role involve regulatory inspections?
The Manager supports inspection readiness related to clinical systems and validation documentation.

5. What are the growth prospects?
Career progression may include Senior Manager – Clinical Systems, Director – Clinical Technology, or broader Clinical Operations leadership roles.

Application Tips

• Highlight your experience with clinical systems such as EDC, CTMS, or eTMF platforms.
• Demonstrate leadership experience, including team management or cross-functional coordination.
• Emphasize regulatory knowledge and compliance contributions.
• Provide examples of system optimization or performance improvement initiatives.
• Showcase measurable achievements such as efficiency gains, reduced errors, or improved reporting accuracy.