information technology systems, office infrastructure, and administrative operations
, while also supporting regulatory compliance and research-related needs.
They act as the
link between technical support, office management, and clinical teams
to maintain productivity and compliance.
2. End-to-End Responsibilities
A. IT Systems Responsibilities
Infrastructure Management
Install, configure, and maintain servers, desktops, laptops, printers, and network devices.
Manage LAN, WAN, and Wi-Fi networks for uninterrupted connectivity.
Ensure data backup systems are operational and tested regularly.
Software & Application Support
Manage
Clinical Trial Management Systems (CTMS)
,
EDC (Electronic Data Capture)
tools, and other CRO-specific software.
Install and update Microsoft Office 365, antivirus, and other licensed software.
Provide user support for clinical and regulatory applications.
Security & Compliance
Implement data security measures in line with
ICH-GCP
and
21 CFR Part 11
requirements.
Maintain user access controls and audit logs.
Support compliance with GDPR, HIPAA, or other data privacy regulations.
System Monitoring & Troubleshooting
Resolve hardware/software/network issues promptly.
Monitor system performance and ensure minimal downtime.
Coordinate with vendors for AMC (Annual Maintenance Contracts).
Data Management
Oversee secure storage of trial data, site files, and backups.
Ensure archival of documents as per regulatory timelines.
B. Administration Responsibilities
Office Operations
Maintain office supplies, utilities, and facility management.
Manage vendor relationships for stationery, utilities, repairs, and AMC services.
Organize housekeeping and ensure workplace cleanliness.
HR & Staff Support
Assist HR in onboarding/offboarding of employees (ID cards, email creation, system allocation).
Maintain attendance, leave records, and employee asset registers.
Regulatory & Documentation Support
Maintain SOP records, meeting minutes, and correspondence files.
Support internal and external audits (regulatory inspections, sponsor audits).
Ensure proper filing of essential documents for clinical studies.
Logistics & Procurement
Manage procurement of IT equipment, clinical supplies, and office needs.
Maintain inventory and asset registers.
Arrange courier and shipment of study-related materials.
Event & Meeting Coordination
Coordinate investigator meetings, training sessions, and internal reviews.
Arrange travel bookings, accommodation, and transport for staff and visitors.
3. Skills & Competencies Required
Strong
IT troubleshooting skills
(hardware, software, networking).
Knowledge of
clinical research software and regulatory requirements
.
Good communication and coordination skills.
Ability to handle