摘要
Location: Hyderabad, India
Novartis 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 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.
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? http://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
