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Clinical Data Mapper

Novartis
Novartis
3-5 years
Not Disclosed
10 March 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Mapper - India

Job ID: REQ-10032691
Date: Mar 04, 2025
Location: India
Division: Biomedical Research
Business Unit: Innovative Medicines
Site: Hyderabad (Office)
Company: Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-Time
Employment Type: Regular
Shift Work: No


Summary:

  • Assist in the timely and professional management of data operations on use cases/demand deliverables within the Clinical Pipeline team.
  • Maintain the clinical data warehouse with a focus on cost, quality, and timelines.
  • Ensure high-quality clinical data is available for secondary analysis use.
  • Support content development and upgrade training modules into engaging and interactive applications.
  • Follow data regulations, laws, handling procedures, and mapping guidelines.
  • Manage data load and transfer from Novartis Clinical Data Lake and ensure compliance with SDTM/ADaM standards.
  • Contribute to the execution of use cases/demands efficiently and deliver high-quality outputs.

Major Accountabilities:

  • Demonstrate technical proficiency, scientific creativity, collaboration, and independent thought.
  • Assist in writing specifications for use cases/demands and ensure high-quality, consistent data.
  • Conduct User Acceptance Testing (UAT) and manage data mapping activities.
  • Review data from different sources and ensure quality control.
  • Support communication initiatives for data-related projects.
  • Perform hands-on data quality assessments.
  • Develop data dictionaries, ontologies, and vocabularies.
  • Report technical complaints and special case scenarios related to Novartis data.
  • Collaborate with data engineering teams to maintain CDISC-based data standards.
  • Understand clinical study documents from protocol to CSR, including Data Management and Biostatistics documents.

Key Performance Indicators:

  • High level of quality, timeliness, cost efficiency, and customer satisfaction in Clinical Data Operations.
  • No critical data findings due to Data Operations issues.
  • Compliance with Novartis policies, data standards, and guidelines.
  • Positive customer/partner/project feedback.

Minimum Requirements:

Work Experience:

  • 3-5 years of experience in clinical trials data reporting.
  • Experience in collaborating across boundaries.
  • Knowledge of clinical data and the ability to find and understand data.
  • Experience with data quality assessments.
  • Exposure to Agile methodologies is a plus.

Skills:

  • CDISC SDTM/ADaM Mapping
  • Clinical Data Management
  • Ability to work with legacy, historical, and local data standards
  • Basic SQL knowledge
  • Python skills (preferred)
  • Ability to work in a global team
  • Understanding of Data Privacy, Data Operations, and Data Science
  • Strong knowledge of databases and data handling
  • Detail-oriented mindset

Languages:

  • English (Required)

Why Novartis?

At Novartis, we go beyond innovative science—we build a community of smart, passionate individuals dedicated to changing patients' lives. If you’re ready to make a difference, we invite you to join our team!

Explore more about our people and culture:
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Novartis Strategy & Culture

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Discover our employee benefits & rewards:
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Benefits & Rewards Handbook


Accessibility & Accommodation:

Novartis is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance in the recruitment process or need accommodation to perform job responsibilities, please email diversityandincl.india@novartis.com with the job requisition number in your message.

Novartis is dedicated to fostering an inclusive and diverse work environment that represents the patients and communities we serve.