Director Clinical Data Standards

Novartis India; Hyderabad; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Novartis India is seeking a Head of Clinical Data Standards (CDS) to lead a global team driving data standards and automation across the organization. The role focuses on scalable, compliant data standards for regulatory submissions and analytics, in collaboration with GDO and external peers.

The candidate will oversee KPIs, policies, and processes, ensuring ROI for the standards landscape while aligning with scientific and regulatory needs.

Qualifications

• Work Experience: People Challenges.
• Functional Breadth.
• Geographic Scope.
• Skills: Automation, Biostatistics, Clinical Trials, Computer Programming.
• Data Analytics, Data Strategy, Decision Making, Global Project Management.
• Metadata Management, Statistical Analysis, Languages: English.

Responsibilities

• Manage a global team(s) of Clinical Data Standards Specialists providing operational, technical and strategic management and development of teams.
• Accountable for all aspects of Clinical Data Standards delivery within assigned discipline including the strategy and planning to ensure the successful development and maintenance of end-to-end data and reporting standards.
• 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.
• Support the development and maintenance of a high performing, industry-recognized Data Operations Organization.

Skills

Automation

Biostatistics

Clinical Trials

Computer Programming

Cross-Functional Teams

Data Analytics

Data Strategy

Decision Making

Global Project Management

Metadata Management

Statistical Analysis

English

Job description

SummarySupports Head CDS in setting the standards and automation strategy across Novartis. Manage a global team(s) responsible for executing data standards / automation objectives across DO. Responsible for ensuring quality, scalable, reusable, (CDISC and regulatory) compliant data standards and technologies are transparently deployed across GDO in close collaboration with external industry peers and internal stakeholders delivering stellar customer focus. Responsible for planning and overseeing KPIs/metrics, frameworks,policies, business rules and processes for development, maintenance, deployment. Responsible to ensure Novartis fulfills a ROI across the standards and automation landscape.

About The Role

Manage a global team(s) of Clinical Data Standards Specialists providingoperational, technical and strategic management and development of teams . Accountable for all aspects of Clinical Data Standards delivery within assigneddiscipline including the strategy and planning to ensure the sucessful developmentand maintenance of end-to-end s data and reporting standards in one or moredisciplines of data acquisition and tabulation, analysis and reporting and/orregulatory data submission across multiple disease/therapeutic areas and drugdevelopment phases . In collaboration with stakeholder and partner functions across and outside of GDO,accountable for driving standards implementation across the organization anddefines and monitors KPIs/metrics, strategies, frameworks, policies, businessrules and processes for development, maintenance, deployment and adoption witha strong focus on scientific and regulatory needs. Lead the technical review and assessment of industry and regulatory standardsand technologies supporting regular gap/impact analysis and implementation ofaction plans where needed. Act as an expert consultant /SME providing Clinical Data Standards input to allrelevant areas including; electronic data capture/database programming, editcheck programming, report programming, electronic data loads, IVR technology,electronic patient reported outcomes, metadata management and/or other clinicaldata management or analysis data and TFL-related systems. Support the development and maintenance of a high performing, industryRecognized Data Operations Organization May also represent at internal and external decision boards and deputise for HeadCDS as required.

Minimum Requirements

• Work Experience: People Challenges.
• Functional Breadth.
• Geographic Scope.
• People Leadership.
• Project Management.
• Collaborating across boundaries.
• Representing the organization.
• SkillsAutomation.Biostatistics.Clinical Trials.Computer Programming.Cross-Functional Teams.Data Analytics.Data Strategy.Decision Making Skills.Global Project Management.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 https://www.novartis.com/about/strategy/people-and-cultureJoin 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: https://talentnetwork.novartis.com/network

Benefits and Rewards:

Read our handbook to learn about all the ways well help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards