Principal Clinical Data Standards Specialists

2+ 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

Principal Clinical Data Standards Specialist
Job ID: REQ-10027702
Date: Mar 03, 2025
Location: India

Summary

Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development, including evaluation of requirements, design specifications, interface to programmers, report programming, coordinating validation, and rollout activities, along with providing quantitative analytical support.

Provide statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas.

Responsible for advising/leading the planning, development, and implementation of Industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including:

Data standard collection tools in EDC (CRFs, edit checks, derivations, core configurations)
Data transfer specifications
Analysis data/TFL standards/Define
Automation solutions/technologies
Business infrastructure, business rules, and guidelines

About the Role

Major Accountabilities:

Drive the implementation of data analytics reports and dashboards for optimal data review by working with users to establish robust user specifications and with programmers to implement the optimal output.
Translate business requirements into logical models and provide direction to the development team to translate business logic.
Lead authoring of the user requirements document, functional specifications, and functional testing scripts.
Proactively identify or address needs for optimal data review, working with users and programmers as appropriate.
Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner.
Provide coordination between project resources to ensure deadlines are met on deliverables.
Drive development of appropriate user training.
Drive all necessary change management activities related to the implementation of new data review tools/reports as related to data cleaning, review, and visualization.
Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
Distribution of marketing samples (where applicable).

Key Performance Indicators:

Timely execution of projects and data requests.
Feedback from project sponsors and key stakeholders.
Adherence to Novartis policy and guidelines.
Metrics and adherence to KPIs.

Minimum Requirements

Work Experience:

Functional Breadth
Cross-Cultural Experience
Managing Crises
Collaborating Across Boundaries
Operations Management and Execution

Skills:

Automation
Biostatistics
Clinical Trials
Computer Programming
Metadata Management
Statistical Analysis

Languages:

English

Why Novartis?

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Learn more.

Join our Novartis Network

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: Join Here.

Benefits and Rewards

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Benefits & Rewards.

Additional Information

Division: Development
Business Unit: Innovative Medicines
Location: India
Site: Mumbai (Office)
Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Alternative Location 1: Hyderabad (Office), India
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No

Accessibility and Accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process or to perform the essential functions of a position, please send an email to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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