摘要
As a Clinical Trial Senior Manager, you will be a core member of the Clinical Trial Team, independently managing all vendor-related aspects of global clinical trials to deliver study outcomes within schedule, budget, quality/compliance and performance standards and be accountable for vendor service delivery at study level.
About the Role
Key Responsibilities
- Serve as the independent leader of the CTT vendor sub-team and a key member of the clinical trial team, working closely with the study lead and other team members throughout the duration of the study.
- Review and translate vendor-related protocol sections into external service requirements and review vendor specification documents.
- Work with Vendor Start-up Manager on developing the Study Specification Worksheet to aid the bid process.
- Accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
Essential requirements:
- 3+ years of experience in clinical operation processes and direct vendor management. This includes direct management of at least two key clinical study vendors, such as IRT, labs, eCOA, PRR, ECG, imaging. Additionally, experience in clinical trial design, mapping to supplier requirements, and the sourcing and contracting of these services is advantageous.
- Excellent knowledge of GxP and ICH regulations.
- User Acceptance testing for eCOA or IRT.
- Site collaboration and site activation.
- Basic understanding of external data generation and data validation processes (e.g. third party data transfer specifications, third party data reconciliation)
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
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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: https://talentnetwork.novartis.com/network
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
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: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
