Study Start-Up Lead

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 teams

representative 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.

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