Study Start-up Lead

Novartis

Hyderabad, India
Clinical trial start-up management
Global regulatory submissions
Vendor and budget management
The Study Start-Up Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country Health Authorities and Ethics Committee submissions and site activation to meet ambitious recruitment plans

Job Summary

  • The Study Start-Up Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country Health Authorities and Ethics Committee submissions and site activation to meet ambitious recruitment plans.
  • The role involves leading a sub-team across multiple functions including vendor management, regulatory, grants and contracts, translations, and clinical supplies to accelerate study and site activation.
  • Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities they serve, providing reasonable accommodations for individuals with disabilities.

Matching Summary

The Study Start-Up Lead plans and executes global SSU activities to ensure timely trial document and task completion to enable country Health Authorities and Ethics Committee submissions and site activation to meet ambitious recruitment plans.

Skills & Requirements

Must-have

  • Clinical trial start-up management
  • Global regulatory submissions
  • Vendor and budget management
  • Trial Master File (TMF) oversight
  • Cross-functional team leadership
  • Use of clinical trial management systems
  • Protocol and amendment implementation

Nice-to-have

  • Data and digital expertise
  • Effective influencing and negotiation skills
  • Commitment to diversity and inclusion
  • Experience with electronic databases
  • Project planning and reporting analytics

Key Requirements

  • Degree in scientific or health discipline
  • Minimum 2 years clinical operations experience
  • Minimum 1 year global clinical trial contribution
  • Knowledge of Good Clinical Practice
  • Experience in project management
  • Experience in pharmaceutical or CRO environment

Work Rights

Not specified

Tailored Resume

Cover Letter