Study Start-Up Lead chez Novartis

Job Description Summary

#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.

 

Job Description

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.

 

Skills Desired

Auditing, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Data Auditing, Data Management, Health Sciences, Lifesciences, Project Planning, Vendor Management, Waterfall Model Postuler maintenant