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    Study Start-Up Lead

    REQ-10061791
    9月 10, 2025
    India

    摘要

    #LI-Hybrid
    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 [email protected] 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

    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: http://talentnetwork.novartis.com/network

    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

    A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
    REQ-10061791

    Study Start-Up Lead

    Apply to Job

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    1. http://www.novartis.com/about/strategy/people-and-culture
    2. http://talentnetwork.novartis.com/network
    3. http://www.novartis.com/careers/benefits-rewards
    4. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Hyderabad-Office/Study-Start-Up-Lead_REQ-10061791-1
    5. mailto:[email protected]
    6. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Hyderabad-Office/Study-Start-Up-Lead_REQ-10061791-1