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Clinical Data Specialist

Company: Novartis

Job ID: 393921BR

Date Posted: May 07, 2024

Location: India

Summary:

The Clinical Data Specialist contributes to various aspects of global clinical trials, ensuring they are conducted within schedule, budget, quality, compliance, and performance standards. This role may involve leading specific aspects of clinical trials and being a core member of the Clinical Trial Team, focusing on operational excellence through process improvement and knowledge sharing.

Major Accountabilities:

  • Contribute to all operational/clinical trial deliverables as specified, adhering to timelines, budget, operational procedures, quality, compliance, and performance standards.
  • Conduct or contribute to study start-up activities, including overseeing protocol development, CRF development, and Informed Consent Form development.
  • May be involved in identifying new sites for clinical trials, analyzing capability, and making recommendations for trial inclusion.
  • Ensure proper handling of all study conduct and close-out activities, including site close-out, final drug accountability, and audit readiness of Trial Master File documentation.
  • Responsible for education, implementation, and compliance with standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trials and programs, including sharing lessons learned.
  • Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.
  • Distribute marketing samples where applicable.

Key Performance Indicators:

  • Timely, efficient, and quality execution of assigned trials and related activities within budget and compliance with quality standards.
  • Proactive operational planning with effective contingency and risk mitigation plans.
  • Adherence to Novartis policy, guidelines, and external regulations.

Skills:

  • Trial Planning and Feasibility.
  • Over The Counter Product Development.
  • Post Authorization Data Safety.
  • Regulatory Strategy.
  • Clinical Trial Set-up, Management & Conduct.

Languages:

  • English

Application Link

2 thoughts on “[Freshers] Novartis Hiring Clinical Data Specialist”

  1. Dear team,
    I am Nayana kuldhar
    I have about 3.5 years experience in research and development department in syngenta bioscience pvt ltd goa.
    I have completed my M.Sc from HPT Arts and RYK Science college nashik (2020).
    Currently I am working in aragen life science hyderabad.
    I am looking for opportunity to work in this company.

    I am sending you my resume for your reference, kindly look and let me know if there is any opportunity.
    Thanks.

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