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    Trial Vendor Associate Director

    Novartis
    5+ years
    Not Disclosed
    Remote
    10 Dec. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Trial Vendor Associate Director
    Company: Novartis
    Location: Dublin, Ireland (Hybrid, 12 days per month in the office)
    Division: Development
    Business Unit: Innovative Medicines
    Functional Area: Research & Development
    Employment Type: Full-time, Regular

    About the Role

    As a core member of the Clinical Trial Team (CTT), the Trial Vendor Associate Director is accountable for vendor service delivery at the study level, managing all clinical vendor-related aspects of global clinical trials. This role ensures that vendor-related activities meet quality and service level standards and supports the efficient execution of global clinical trials.

    Key Responsibilities

    • Vendor Collaboration: Work closely with the study team lead and members, managing the interface with vendors and vendor partner functions during the study lifecycle.
    • Protocol Development Support: Review vendor-related protocol sections during protocol development.
    • Vendor Management: Oversee the quoting and proposal review in collaboration with procurement, support contract negotiations, and contribute to the development of vendor contract amendments. Responsible for vendor cost control, budget review, invoice reconciliation, and PO close-out.
    • Service Excellence: Ensure vendors meet quality and service standards for clinical trials, with accountability for service delivery post-study start-up.
    • Study Start-Up & Activation: Manage vendor-related activities for study start-up, including vendor kick-off meetings and site activation. Optimize frontloaded, timely study start-up processes.
    • Risk Management: Create and maintain vendor-related risk maps with contingency plans for documentation in FIRST.
    • User Acceptance Testing (UAT): Conduct UAT for eCOA and IRT systems.
    • Cross-Functional Collaboration: Work with Data Ops to review vendor-related cycle times and monitor site activation progress, addressing any issues or risks.

    Qualifications

    • Experience:
      • Minimum 5+ years of experience in clinical operations and vendor management.
      • Strong knowledge of clinical trial design, GxP, ICH regulations, and Novartis specifications for supplier-provided services.
      • Demonstrated experience in user acceptance testing for eCOA and IRT systems.
    • Skills:
      • Strong vendor management skills, including outsourcing, contracting, and sourcing clinical services.
      • Ability to work effectively in cross-functional teams within a matrixed environment.
      • Excellent influencing, negotiation, and problem-solving skills.
      • Strong interpersonal and communication skills.
      • Proven ability to complete projects on time and manage vendor-related activities with excellence.

    Why Novartis?

    At Novartis, we are dedicated to reimagining medicine to improve and extend people’s lives. Join us to collaborate with passionate people, work on groundbreaking innovations, and contribute to improving patient outcomes.

    Commitment to Diversity & Inclusion

    Novartis is committed to creating an inclusive environment with diverse teams that represent the patients and communities we serve.

    Benefits and Rewards

    Novartis offers a comprehensive benefits package to support personal and professional growth. Learn more about our offerings here.

    Join the Novartis Network

    If this role is not the right fit, join our talent community to stay updated on future opportunities here.

    For more details about this position or to apply, visit the Novartis Careers page.

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