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Clinical Data Mapper

Novartis

3-5 years

Not Disclosed

Hyderabad

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:
🔗 Novartis Strategy & Culture

Not the right role for you? Stay connected with us!
🔗 Join our Talent Community

Discover our employee benefits & rewards:
🔗 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.

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Clinical Data Mapper

Job Description

Summary:

Major Accountabilities:

Key Performance Indicators:

Minimum Requirements:

Work Experience:

Skills:

Languages:

Why Novartis?

Accessibility & Accommodation:

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