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Clinical Data Specialist Ii

2+ years
Not Disclosed
10 Aug. 22, 2024
Job Description
Job Type: Full Time Remote Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

As a Clinical Data Specialist II at Novartis, you play a pivotal role in ensuring the successful delivery of global clinical trials by adhering to schedule, budget, and compliance standards. You will be involved in all aspects of clinical trial activities, from study start-up to close-out, and will provide critical support through data review and insights. You contribute to operational excellence by improving processes, sharing knowledge, and supporting the clinical development process. As a core member of the Clinical Trial Team (CTT), you will help drive high-quality outcomes and maintain rigorous adherence to Novartis policies and regulatory requirements.

About the Role

Major Accountabilities:

  • Oversee and contribute to all operational and clinical trial deliverables, ensuring they are completed on time, within budget, and in compliance with quality and performance standards.
  • Lead or support study start-up activities, including protocol development, CRF design, and Informed Consent Form creation.
  • Manage study conduct and close-out activities, ensuring proper documentation and audit readiness of Trial Master Files.
  • Educate and enforce adherence to clinical operations standards, SOPs, and best practices, and actively share lessons learned.
  • Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours.
  • Distribute marketing samples where applicable.

Key Performance Indicators:

  • Deliver trials and related activities timely, efficiently, and within budget while meeting quality standards.
  • Develop proactive operational plans with effective risk mitigation strategies.
  • Maintain strict adherence to Novartis policies, guidelines, and external regulations.

For Clinical Scientific Expert II:

  • Consistently perform high-quality clinical data reviews, meeting Novartis standards and ensuring inspection readiness.
  • Contribute effectively to study/program level documents, including IDPs, protocols, ICFs, and clinical sections of CTAs.
  • Demonstrate leadership by supporting team competency building, leading local/global initiatives, and sharing best practices across programs and departments.
  • Exemplify Novartis Values and Behaviors: Innovation, Quality, Collaboration, Performance, Courage, and Integrity.

Minimum Requirements

Work Experience:

  • Financial Management
  • Collaboration across boundaries
  • Operations Management and Execution
  • Project Management

Skills:

  • Budget Management
  • Clinical Research
  • Clinical Trial Protocol Development
  • Clinical Trials Execution
  • Coaching and Mentoring
  • Data Analysis and Integrity
  • Learning Design
  • Risk Monitoring
  • Trends Analysis

Languages:

  • Proficiency in English

Why Novartis

At Novartis, we believe that transforming healthcare requires more than just cutting-edge science. It demands a community of dedicated, passionate professionals working together to achieve breakthroughs that improve patients' lives. Join us in creating a brighter future through collaboration and innovation. Explore more about our values and culture here and connect with our talent community here.

Division: Biomedical Research
Location: Hyderabad, India
Company / Legal Entity: Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time