Senior Clinical Data Mapper

Novartis

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

Senior Clinical Data Mapper - India

Job ID: REQ-10032362
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:

Provide 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.
Develop and refine training modules for Clinical Data Mapper onboarding.
Leverage AI-based Clinical Pipeline technology to enhance process simplification and training.
Follow data privacy, data handling procedures, and guidelines.
Collaborate with Data Scientists, Data Services, and stakeholders to ensure high-quality legacy data mapping efforts.
Manage data load and transfer from Novartis Clinical Data Lake and ensure compliance with SDTM/ADaM standards.
Lead the execution of use cases/demands, ensuring high-quality and timely deliverables.

Major Accountabilities:

Lead data mapping efforts across assigned use cases/demands.
Act as the Clinical Data Mapper Lead when required.
Allocate tasks for the Clinical Data Mapper team based on priority.
Identify and resolve conflicts in data flows or data standards.
Define and implement new quality checks and validation processes.
Ensure full compliance with global regulatory requirements including data privacy.
Maintain clinical data and metadata catalogs.
Contribute to data dictionaries, ontologies, and vocabularies.
Conduct data quality assessments.
Support Clinical Data Mapper staff on assigned use cases/demands.
Drive Data Operations innovations for efficiency and continuous improvement.
Serve as the primary Data Mapper, ensuring timely and quality deliverables.
Act as a CDISC SDTM/ADaM expert when needed.
Collaborate with Data Scientists to address data mapping complexities.
Lead or participate in Clinical Pipeline technology improvement initiatives.
Work closely with the Data Engineering team to support complex data transformations.
Be familiar with clinical study documents, from protocol to CSR.

Key Performance Indicators:

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

Minimum Requirements:

Work Experience:

5+ years of experience in clinical data management.
Strong CDISC knowledge (SDTM/ADaM).
Understanding of Clinical Data Lifecycle.
Ability to work with various data standards.
Knowledge of Data Privacy regulations.
Experience in cross-cultural environments.
Familiarity with Agile methodologies (preferred).
Project Management experience.

Skills:

Clinical Data Management
Data Governance
Data Integrity
Data Operations
Data Quality
Data Privacy
Databases
Project Management
SAS/SQL knowledge
Python (preferred)
Artificial Intelligence (optional)

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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