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Senior Clinical Data Mapper

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

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.