Study Start-Up Lead

Summary

Location: Hyderabad, IndiaNovartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About The Role:

Are you passionate about driving clinical trial excellence from the ground up? Novartis Global Drug Development is seeking a dynamic Study Start-Up Lead to spearhead global SSU activities, ensuring timely site activation and regulatory submissions. This is your opportunity to lead cross-functional teams and make a meaningful impact in global health innovation.

About The Role

Key Responsibilities:

• Lead global SSU planning and execution to enable timely site activation and regulatory submissions.
• Configure and manage SSU systems including CTMS, eTMF, and vendor tools.
• Oversee global trial document readiness and ensure TMF inspection readiness.
• Drive transparency and alignment across countries for SSU deliverables.
• Collaborate with cross-functional teams including Regulatory, Vendor Management, and Clinical Supplies.
• Provide proactive risk management and implement corrective actions as needed.
• Support country SSU Managers to ensure timely site readiness and compliance.
• Ensure budget processes and approvals align with SSU timelines.
  

Essential Requirements:

• Bachelor’s degree in a scientific or health discipline
• Minimum 2-3 years’ experience in clinical operations or trial monitoring.
• Minimum 1 years of contribution to and accomplishment in all aspects of conducting clinical trials
• Strong knowledge of GCP, clinical trial setup, and global drug development.
• Demonstrated effective influencing and negotiation skills at all levels.
• Excellent communication, influencing, and negotiation skills.
• Proficiency in digital tools and data-driven decision-making.
• High learning agility and willingness to champion new technologies.
  

Commitment To Diversity And Inclusion / EEO Paragraph:

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

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.

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