Information Technology Support Engineer

2 years

0 Lacs

Posted:2 days ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

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Experience


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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