Associate Director- Clinical Data Standards

3+ years

Not Disclosed

Mumbai

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

Associate Director- Clinical Data Standards
Job ID: REQ-10022081
Date: Mar 03, 2025
Location: India

Summary

Strategically and tactically supports the Director of Clinical Data Standards. 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
May lead global teams.

About the Role

Major Accountabilities:

Ensuring alignment with the CDS strategy; responsible for Clinical Data Standard/automation solution planning, definition, development, validation, and support.
Serves as the primary contact for global/TA data standards and/or technologies, ensuring timely and quality deliverables.
Responsible for driving efficient, high-quality, and timely implementation of new standards and/or technologies.
Ensure efficient governance and approval of global clinical data standards/technologies, liaising with governance boards as needed.
Lead the technical review and assessment of industry and regulatory standards and technologies, supporting regular gap/impact analysis and implementation of action plans where needed.
Lead and contribute to the development, maintenance, and training of relevant clinical standards systems and processes.
Act as an expert consultant providing Clinical Data Standards input to all relevant areas, including electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient-reported outcomes, metadata management, and/or other clinical data management or analysis data and TFL-related systems.
Act as the primary subject matter expert (SME) for the assigned area, providing support, consultation, and training to end users and SME networks on the implementation of standards and related tools on development programs.
Provide mentoring and technical guidance to Clinical Data Standards associates; contribute to the effectiveness and development of talent.

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.

Work Experience:

Managing Crises
Functional Breadth
Project Management
Collaborating Across Boundaries
Representing the Organization

Skills:

Automation
Biostatistics
Clinical Trials
Computer Programming
Cross-Functional Teams
Data Analytics
Decision-Making Skills
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?
Novartis Strategy - People and Culture

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:
Novartis Talent Network

Benefits and Rewards

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

Additional Details

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 in order to perform the essential functions of a position, please send an e-mail 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.a

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