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About Company

Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance, and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. Contributes to operational excellence through process improvement and knowledge sharing.

Position Name :

Clinical Data Specialist

Organization :

Novartis

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

1 to 2 Years

Salary:

₹5.7 Lakhs to ₹9.2 Lakhs

Location:

India

About the Role

Major Accountabilities:

  • Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality/compliance, and performance standards.
  • Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF development, and Informed Consent Form development.
  • May/may not be involved in identifying new sites for clinical trials; analyze capability and make recommendations for trial inclusion.
  • Ensuring proper handling of all study conduct and close-out activities including but not limited to site close-out, final drug accountability, and audit readiness of Trial Master File documentation (if in scope of the specific JD).
  • Responsible for education, implementation, and compliance with standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
  • Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
  • Distribution of marketing samples (where applicable).

Key Performance Indicators:

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

Minimum Requirements:

Work Experience:

  • Operations Management and Execution.
  • Project Management.
  • Financial Management.
  • Collaborating across boundaries.

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