Clinical Data Specialist II Position

2 days ago


Hyderabad, Telangana, India Lifelancer Full time

Overview

Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT. We're seeking an experienced Clinical Data Specialist II to join our team.

About the Role

  • We're looking for a highly skilled individual to contribute to all aspects of global clinical trial activities, ensuring timely delivery within budget, quality, and performance standards.
  • This role involves leading specific aspects of global clinical trials, collaborating with cross-functional teams, and driving operational excellence through process improvement and knowledge sharing.
  • You'll work closely with the Clinical Trial Team to ensure data integrity, scientific plausibility, and compliance with regulatory requirements.

Main Responsibilities

  • Contribute to study start-up activities, including protocol development, CRF creation, and Informed Consent Form development.
  • Oversee site close-out, final drug accountability, and audit readiness of Trial Master File documentation.
  • Implement and enforce standards (SOPs) and best practices for clinical operations and data review within assigned clinical trials and programs.
  • Ensure timely reporting of technical complaints, adverse events, and special case scenarios related to Novartis products.

Key Performance Indicators

  • Timely, efficient, and high-quality execution of assigned trials within budget and quality standards.
  • Proactive operational planning with effective contingency and risk mitigation plans.
  • Adherence to Novartis policy and guidelines, as well as external regulations.
  • High-quality contributions to study/program-level documents and submissions.
  • Strong leadership skills to support team competency building, local/global initiatives, and best practice sharing.

Requirements

  • Financial management experience.
  • Collaboration across boundaries.
  • Operations management and execution.
  • Project management expertise.

Skills

  • Budget management.
  • Clinical research.
  • Clinical trial protocol.
  • Clinical trials.
  • Coaching.
  • Data analysis.
  • Data integrity.
  • Learning design.
  • Lifesciences.
  • Risk monitoring.
  • Trends analysis.

Estimated Salary: $85,000 - $110,000 per year, depending on location and experience.



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