Job Title

Position: Software Engineer/ IT Support Engineer – Clinical ResearchDepartment: IT / Research TechnologyLocation: Indiranagar, BangaloreEmployment Type: Full-time/ ConsultantExperience: 2-4 yearsJob SummaryWe are seeking a Software Engineer / IT Support Engineer to support technology systems used in clinical research and pharmacovigilance operations. The role involves managing secure IT infrastructure, supporting validated systems, and ensuring compliance with clinical research regulatory requirements. The candidate will work closely with research, data management, and quality teams to ensure systems operate smoothly, securely, and in line with GAMP 5 and other industry standards.Key Responsibilities- Set up, monitor, and maintain secure VPN connections and access to clinical research platforms. - Support cybersecurity activities including user creation, access management, security checks, and patch updates in line with data protection and regulatory needs. - Assist with cloud environment maintenance (Microsoft Azure or similar), especially for research data applications. - Install, configure, and manage Microsoft Office 365 Enterprise tools (Outlook, SharePoint, Teams) used by clinical and research teams. - Provide technical support for clinical systems such as CTMS, eTMF, EDC, Lab systems, or other validated tools (training can be provided). - Ensure compliance with GAMP 5 guidelines, data integrity principles (ALCOA+), and basic understanding of 21 CFR Part 11 for computerized systems. - Support system validation activities such as user access mapping, change control documentation, and periodic review support. - Coordinate with IT, QA, and research data teams to ensure that clinical research data is securely stored, backed up, and protected at all times. - Troubleshoot software, hardware, and connectivity issues impacting clinical operations.Qualifications- Bachelor’s degree or diploma in Computer Science, IT, or related field. - 2–4 years of experience in IT support, software setup, system administration, or supporting cloud-based systems. - Basic understanding of clinical research operations or willingness to learn (CRO/Pharma experience preferred). - Knowledge of VPN setup, cloud infrastructure, and cybersecurity practices. - Experience managing Microsoft Office 365 Enterprise and user administration. - Familiarity with GAMP 5, computerized system lifecycle, or regulated environments (preferred). - Awareness of 21 CFR Part 11 and data integrity principles is an added advantage. - Strong problem-solving, communication, and documentation skills. - High attention to detail and ability to follow clinical data protection protocols.