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Clinical Data Scientist

3+ years
Not Disclosed
10 Nov. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Clinical Data Scientist

Location: Mumbai, India (#LI-Hybrid)
Job ID: REQ-10029994
Company: Novartis Healthcare Private Limited
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development

About the Role

The Clinical Data Scientist is responsible for utilizing advanced data management tools and techniques to ensure the execution of Data Management (DM) products and milestones within Clinical Data Acquisition and Management. The role ensures that high-quality data is consistently available for analysis and reporting throughout the course of clinical trials.

Key Responsibilities

  • Data Management for Clinical Trials:

    • Provide data management input and may act as Trial Data Scientist on smaller, low-complexity trials.
    • Perform study startup activities, including preparing eCRF, Data Quality Plan (DQP), and conducting User Acceptance Testing (UAT).
    • Manage local lab setup for clinical databases and ensure consistency with program-level standards.
  • Third-Party Data & Quality Review:

    • Review data from clinical studies, including third-party and local lab data, and reconcile Serious Adverse Events (SAEs).
    • Track eCRF completion, resolve queries, and provide data status updates to the study teams.
  • Study Support and Documentation:

    • Develop proposals to resolve issues during trial execution.
    • Provide input for Study Specification worksheets when trials need to be outsourced.
    • Generate study status reports for Clinical Trial Team meetings.
  • Regulatory & Technical Knowledge:

    • Maintain familiarity with FDA and ICH guidelines.
    • Utilize available tools to generate data listings for review and provide these to study teams.

Essential Requirements

  • Education: University degree in life sciences, computer science, pharmacy, nursing, or an equivalent relevant field.
  • Experience:
    • Ideally, 3 years in Drug Development, with at least 2 years in Clinical Data Acquisition & Management.
  • Skills:
    • Strong technical skills.
    • Fluent in English, both verbal and written.

Why Novartis?

Novartis is dedicated to improving and extending lives through innovative medicines, and our people are at the core of this mission. By joining Novartis, you will be part of a community that strives to achieve breakthroughs that can change patients' lives.

Benefits and Rewards

Learn more about the benefits and rewards offered to Novartis employees: Novartis Life Handbook.

Commitment to Diversity & Inclusion

Novartis is committed to creating an inclusive work environment that reflects the diversity of the patients and communities we serve.

Join the Novartis Network

If this role is not aligned with your current experience or career goals but you wish to stay updated about future opportunities, join the Novartis Talent NetworkNovartis Talent Network.