Information Technology Support Engineer

3 weeks ago

New Delhi, India MS CLINICAL RESEARCH Full time

Position:Software Engineer/ IT Support Engineer – Clinical Research Department:IT / Research Technology Location:Indiranagar, Bangalore Employment Type:Full-time/ Consultant Experience : 2-4 yearsJob Summary We 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 secureVPN connectionsand access to clinical research platforms. Support cybersecurity activities includinguser creation, access management, security checks, and patch updatesin line with data protection and regulatory needs. Assist withcloud environment maintenance(Microsoft Azure or similar), especially for research data applications. Install, configure, and manageMicrosoft Office 365 Enterprise tools(Outlook, SharePoint, Teams) used by clinical and research teams. Provide technical support forclinical systemssuch as CTMS, eTMF, EDC, Lab systems, or other validated tools (training can be provided). Ensure compliance withGAMP 5 guidelines ,data integrity principles (ALCOA+), and basic understanding of 21 CFR Part 11for 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 issecurely stored, backed up, and protectedat 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 ofclinical research operationsor willingness to learn (CRO/Pharma experience preferred). Knowledge ofVPN setup, cloud infrastructure, and cybersecurity practices . Experience managingMicrosoft Office 365 Enterpriseand user administration. Familiarity withGAMP 5 , computerized system lifecycle, or regulated environments (preferred). Awareness of21 CFR Part 11and data integrity principles is an added advantage. Strong problem-solving, communication, and documentation skills. High attention to detail and ability to followclinical data protection protocols .

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