REQ-10048338
4月 11, 2025
India

摘要

The Head, Clinical Programming and Technology is an established strategic leader with a strong understanding of technology and it’s impact on the drug development process, with significant experience in developing and contributing to the development of technological tools from data collection to analytical outputs and data submission standards, with an excellent knowledge of relevant aspects of Clinical Data Operations;

About the Role

Major accountabilities:

  • Architect and oversee development, execution and maintenance of scalable technology platforms
  • Manage a global team(s) of Clinical Technology Specialists responsible for developing, maintaining and supporting the automation and technology interventions across Clinical Data Operations
  • Manage a global team(s) of Clinical Programming specialists responsible for developing, maintaining clinical trial electronic data capture applications, clinical trial data acquisition and provisioning of data to various downstream applications, providing and enabling reports and visualization analytics for CDO and other Development functions
  • In collaboration with stakeholder and partner functions across and outside of GCO, drives technology and automation implementation across the organization and defines and monitors KPIs/metrics, strategies, frameworks, policies, business rules and processes for development, maintenance, deployment and adoption with a strong focus on scientific and regulatory needs.
  • Establish a continual and demonstratable Return-On-Investment paradigm for the technology interventions across Clinical Data Operations
  • Define the strategic vision for Clinical Technology for Global Clinical Data Operations and oversee the deployment plan to realize this vision. Ensures awareness of trends in the industry and tracks new capabilities and technologies to ensure Clinical Data Operations operates at the cutting edge of available technology.
  • Accountable for all aspects of Clinical Programming and Technology delivery, including strategy and planning to ensure successful development and maintenance of technology and automation interventions.
  • Translates multi-year strategic vision of technology into year-on-year goals and objectives and ensures objectives are aligned upward with CDO / GCO / Development technology strategy. 
  • Drives the governance for all technology and automation projects within Clinical Data Operations and all relevant stakeholders; tracks and measures the ROI and impact for cost, speed, productivity and quality
  • Build and maintain strong partnerships within Development with special focus on technology teams - ASCEND, DIT and GCO SIT etc.,
  • Lead the strategy and direction (including development of capabilities) for Clinical Programming teams – Database Programming (DBP), Database Acquisition and Provisioning (DAP) and Data Review Reporting and Analytics (DRRA) teams
  • Lead / contribute to global strategic initiatives for Clinical Programming
  • Building and maintaining strong partnerships within Development for Clinical Programming with special focus on partner functions within CDO and GCO.
  • Ensure CDO at Novartis is considered as industry leading internally and externally; lead, influence, collaborate and proactively shape the external environment including data standards, regulatory guidelines, industry practices and professional organizations.
  • Establish and maintain a high performing, industry recognized CDO organization:

a. Mentor leadership talent and high performing associates. Responsible for performance management, succession planning, professional development, training and mentoring.

b. Establish and steer a business founded on innovation, collaboration, quality, customer service and trust.

c. In collaboration with People and Organization, develop, establish and maintain up-to-date strategies to attract and retain top talent across the globe maintaining a targeted recruitment strategy for key strategic positions.

Key performance indicators:

  • Achieve or exceed versus Clinical Data Operations Strategic Vision, objectives, portfolio, budget and resourcing targets
  • Recognized thought leadership internally and externally across Novartis. 
  • Accurate, timely and efficient management of CDO resources and budget.
  • Rapid assessment and recommendations of new tools, capabilities and technologies to the CDO sub-functions.
  • Measurable improvement in associate (employee) satisfaction, employee engagement and connectedness within Clinical Data Operations (GLINT survey. OurVoice scores etc.,), collaboration and connections across partner line functions within GCO (360 degree feedback, insights).
  • Measurable continuous improvement across delivery metrics in Clinical Data Operations with a clear move towards transforming clinical trials.

Minimum Requirements:

           

·BA/BS/MS or equivalent experience in health sciences, statistics, computer sciences or related field

·At least 15+ years industry experience in global drug development within the pharmaceutical industry. 

·At least 8 year’s team leadership and line management experience preferably leading global teams.

·Expert knowledge and experience in end to end development of technology and tools for Clinical Data.

·Advanced understanding of regulatory requirements relevant to Data Management and Statistical Programming (including GCP, ICH).

·Established leadership skills with a proven track record leading and developing people, teams, and innovation in large complex global matrix structures and business models.

·Proven experience in Stakeholder Management and excellent influencing skills

·Excellent project and resource management skills.

·Excellent understanding of drug development, global clinical trial / project practices, procedures, methodologies.

·Excellent interpersonal and communication skills.

·Outstanding verbal and written skills.

·Proven ability to effectively lead major non-clinical initiatives

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-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: https://talentnetwork.novartis.com/network

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

A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10048338

Head Clinical Programming and Technology

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