Information Technology Support Engineer

18 hours ago

Bengaluru, Karnataka, 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 years

Job 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 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
    .

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