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Trial Vendor Associate Director

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Novartis

1mo ago

  • Job
    Full-time
    Senior Level
  • Research & Development
  • Dublin

AI generated summary

  • You need 5+ years in clinical ops and vendor management, GxP/ICH knowledge, trial design expertise, strong communication and negotiation skills, problem-solving abilities, and teamwork experience.
  • You will collaborate with study teams, manage vendor interactions, review proposals and contracts, ensure service quality, coordinate kick-off meetings, and monitor site activation and risks.

Requirements

  • 5+ 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

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
  • Manage interface with vendors in cooperation with vendor partner functions
  • Quote/proposal review in collaboration with procurement, support contract negotiations, if required
  • Contribute to the development of vendor contract amendments and accountable for vendor cost control, budget review, invoice reconciliation and PO close-out
  • Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
  • Cover all vendor activities after study start-up and all categories not covered by VSMs during start-up
  • Initiate/co-ordinate vendor kick-off meeting for categories not covered by VSMs
  • Attend vendor kick-off meeting for VSM supported categories
  • Optimizing a frontloaded and timely study-start-up process, manage vendor-related activities for DB go live
  • Perform user-acceptance testing (UAT) for eCOA and IRT
  • Drive and monitor central vendor-related activities for site activation, compile Final Protocol Package (FPP) required documents centrally, monitor site activation progress and address related issues and risk
  • Creates and maintains vendor-related risk maps with contingency plan for documentation in FIRST
  • Interact and collaborate with Data Ops, reviews vendor-related cycle times (e.g. DTS finalization, data transfers, DBL)

FAQs

What is the location of the Trial Vendor Associate Director position?

The position is based in Dublin, Ireland.

Is this a remote position?

Yes, this is a hybrid office/home based position with 12 days per month to be performed from the office.

What are the primary responsibilities of the Trial Vendor Associate Director?

The primary responsibilities include managing vendor service delivery at the study level, collaborating with study team members, overseeing vendor-related protocol sections, budget control, invoice reconciliation, ensuring service quality, and managing vendor activities after study start-up.

What qualifications are required for this role?

A minimum of 5 years working experience in clinical operations and vendor management is required, along with excellent knowledge of GxP and ICH regulations, clinical trial design, vendor contract management, and strong problem-solving and communication skills.

Are there opportunities for career development within Novartis?

Yes, Novartis offers various career development opportunities, and candidates are encouraged to stay connected via the Novartis Network for future opportunities.

What is the company's commitment to diversity and inclusion?

Novartis is committed to building an outstanding, inclusive work environment and ensuring diverse teams that represent the patients and communities they serve.

How can I request reasonable accommodation during the recruitment process?

If you need a reasonable accommodation due to a medical condition or disability, you can email diversity.inclusion_ch@novartis.com with details of your request and contact information.

What benefits does Novartis offer?

Novartis provides a range of benefits and rewards, which can be reviewed in the Novartis Life Handbook available on their careers page.

What kind of work environment does Novartis promote?

Novartis promotes a collaborative work environment where smart, passionate people support and inspire each other to achieve breakthroughs that change patients' lives.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

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  • Integrity

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