摘要
We are currently looking for a Trial Vendor Senior Manager (TVSM) to be based in Dublin.
This is a hybrid position with 12 days per month from the office.
#LI-Hybrid
As a core member of the Clinical Trial Team (CTT) independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards, you’ll be accountable for vendor service delivery at study level and collaborate closely with the Vendor Start-up Manager (VSM) for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R), and imaging reading) during study start-up and leverage your technical and study start-up (SSU) expertise to ensure a timely study start-up.
About the Role
Key responsibilities:
- Close interaction and collaboration with study team lead and study team members during study lifetime
- Review of vendor related protocol sections during protocol development
- Collaborate with Vendor Startup Manager to the development of Study Specification Worksheet (SSW) to facilitate bid process. If no Vendor Start Up Manager is assigned to the category, drive the SSW completion.
- Manages interface with vendors in cooperation with vendor partner functions
- Quote/proposal review in collaboration with procurement, support contract negotiations and contributes= to the development of vendor contract amendments
- Accountable for vendor cost control and vendor service excellence
- Initiates/co-ordinates vendor kick-off meeting for categories not covered by Vendor Start Up Managers
- Attends vendor kick-off meeting for Vendor Start Up Manager supported categories
Essential requirements:
- Bachelor degree or equivalent degree is required, with advanced degree preferred.
- Fluent English (oral and written)
- 3+ years working experience and excellent knowledge of the clinical operation processes and vendor management
- Excellent knowledge of GxP and ICH regulations
- Very good knowledge of clinical trial design and mapping to supplier requirements
- Thorough and technical understanding of Novartis specifications for supplier provided services
- User Acceptance testing for eCOA and IRT
- Site collaboration and site activation
- Vendor management; outsourcing, contracting, sourcing, of clinical services
- Results-driven: demonstrated ability of completing projects on time
- Ability to work in cross-functional teams and a matrixed environment
- Strong influencing and negotiation skills
- Good written and oral communications skills
- Very good problem-solving skills
- Demonstrated willingness to make decisions and to take responsibility for such
- Excellent interpersonal skills (team player)
- Proven networking skills and ability to share knowledge and experience amongst colleagues.
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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