摘要
About the Role
Key responsibilities:
- Integrates SSU insights into the trial Operational Execution Plan (OEP), ensuring alignment with milestones and dashboards alongside the Study Leader/CTT.
- Oversees trial-specific setup of SSU systems, including tasks, personnel, vendors, translations, site contracting tools, and templates (e.g., ICF, enrollment plans). Prepares SSU planning and leads the SSU Team from kick-off through completion for global site enrollment, adhering to timelines and trial requirements.
- Ensures timely collection of global trial-level documents for submission and eTMF entry, supporting health authority and Ethics Committee approvals.
- Collaborates with Vendor Program Manager and GCS to ensure vendor activation, site readiness, and clinical supply alignment for site initiation.
- Provides proactive oversight, managing risks to ensure quality SSU execution and adherence to timelines/regulations, implementing corrective actions if required.
- Ensures the proper use of technology platforms, completeness of data, and alignment of global budgets/processes to support SSU activities and timelines. Enables and oversees country Study Start-up Managers to ensure local submission package readiness, IRB/IEC approvals, and timely delivery of SSU deliverables.
Essential requirements:
- Degree in scientific or health discipline required; advanced degree with clinical trial and/or project management experience preferred.
- Fluent English, spoken and written.
- Minimum 2 years overseeing and/or monitoring clinical trials, plus 1 year contributing to their planning, execution, and reporting. Proven ability to engage and lead diverse teams in a global, matrixed environment.
- Excellent influencing, communication, and negotiation abilities at all organizational levels.
- Strong understanding of Good Clinical Practice, clinical trial design, and global drug development processes.
- Experience with electronic systems, clinical/project management analytics, and willingness to embrace new technologies.
- Data-driven mindset and dedication to meeting deadlines effectively.
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
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