Senior Clinical System Administrator
Company: Precision Medicine Group
Location: Bangalore, Karnataka, India
Employment Type: Full-time
Function: Clinical Systems / Clinical Operations Technology
Job Summary
The Senior Clinical System Administrator serves as a subject matter expert (SME) for clinical systems and supports the successful implementation, configuration, integration, and adoption of clinical technology platforms across the organization.
The role involves collaborating with Clinical Operations, IT teams, and business stakeholders to manage clinical system configurations, integrations, user support, validation activities, process development, and compliance requirements.
Key Responsibilities
Clinical System Administration & Configuration
Act as a Clinical Systems Subject Matter Expert (SME) and provide support to end users.
Collaborate with Clinical teams to:
Update existing templates
Add new templates
Configure system features
Enhance clinical workflows
Manage clinical system configurations including:
Templates
Reports
Dashboards
Milestones
User requirements
Perform archival activities within clinical systems as per approved requests and procedures.
Clinical System Integration Management
Oversee integrations between:
Clinical Trial Management Systems (CTMS)
Electronic Data Capture (EDC) systems
Other clinical technology platforms
Provide oversight for EDC and Clinical System integrations.
Support requirement gathering, documentation, testing, and implementation of system integrations.
System Releases, Testing & Validation
Support clinical system upgrades, new version releases, and configuration changes.
Coordinate and execute:
User Acceptance Testing (UAT)
System testing
Validation activities
Ensure system changes meet business requirements and quality standards.
Process Development & Documentation
Create and maintain Clinical System processes, procedures, and user documentation.
Develop training materials and provide guidance to:
Internal clinical teams
External teams
Sponsors
Site staff
Support study teams in independently utilizing CTMS features and capabilities.
User Support & Issue Management
Manage help desk ticket assignments for Clinical System Administrators.
Provide ongoing end-user support and troubleshooting.
Conduct regular user reviews and identify opportunities for system improvement.
Resolve system issues independently while escalating complex issues appropriately.
Audit & Compliance Support
Participate in:
Inspection preparation activities
Audit readiness activities
Compliance reviews
Support development and execution of CAPA (Corrective and Preventive Action) plans when required.
Ensure clinical systems operate according to applicable procedures and regulatory expectations.
Cross-functional Collaboration
Work closely with:
Clinical Operations teams
IT teams
Clinical Systems Managers
Business stakeholders
Translate business requirements into effective technology solutions.
Support Clinical Systems leadership with additional projects and operational activities.
Required Experience
5+ years of experience working with Clinical Systems in pharmaceutical, biotechnology, CRO, or clinical research environments.
Strong experience with clinical trial systems including:
CTMS (Clinical Trial Management System)
EDC (Electronic Data Capture)
eTMF (Electronic Trial Master File)
RTMS (Randomization and Trial Management System)
Experience with:
Requirements gathering
System configuration
Integration management
Documentation
Validation activities
Required Skills & Competencies
Strong understanding of clinical trial technology platforms and workflows.
Ability to analyze business needs and translate them into technical requirements.
Strong troubleshooting and problem-solving abilities.
Ability to independently manage system issues and prioritize tasks.
Excellent communication skills with ability to work with technical and non-technical stakeholders.
Strong interpersonal, written, and verbal communication skills.
Ability to quickly learn new systems and integration requirements.
Educational Qualification
Preferred Qualifications:
Bachelor’s degree or equivalent experience in:
Healthcare
Life Sciences
Business Administration
Clinical Research
Information Technology
Scientific disciplines
Experience Level
Preferred Experience: 5–8+ years in:
Clinical Systems Administration
Clinical Operations Technology
CTMS Administration
EDC System Management
Clinical Trial Technology Solutions
Clinical Systems Implementation & Validation
Suitable Profiles:
Senior Clinical System Administrator
Clinical Systems Specialist
Clinical Systems Manager
CTMS Administrator
Clinical Technology Specialist
Clinical Operations Systems Lead
Salary Package (Market Estimate)
Estimated CTC: ₹15–28 LPA (based on Indian Clinical Systems, CTMS/EDC administration, CRO/pharma technology market standards, experience level, and technical expertise. Official JD does not specify salary.)
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