Vendor & Third Party Management Clinical Project Manager

Vor 2 Tagen

Basel, Schweiz WillHire Vollzeit

This is a temporary contractor opportunity at Novartis

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life

Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit.

Ready to work with/through Magnit at Novartis? Please read on...

Position Purpose:
The role is part of the Vendor and Third-Party Management (V&TPM) team and is responsible for cross-functional coordination with the Evidence Generation team by supporting the V&TPM SPOC responsibility, in overseeing and facilitating the third-party qualification process.

Main activities and key responsibilities:

  • Cross-functional coordination:
    o Act as the main support for Vendor and Third-Party Management (V&TPM).
    o Coordinate V&TPM activities and responsibilities with Evidence Generation study teams (Study Execution + Evidence Generation).
    o Serve as a central point of coordination with Evidence Generation teams by supporting the V&TPM SPOC role (V&TPM acts as the single point of contact for the study teams).
  • End-to-end TPM process management:
    o Oversee the end-to-end process, including liaison with Legal, qualification, RFP, contracting, and PO management.
    o Interface with stakeholders and Novartis functions, providing inputs and updates as needed.
    o Manage qualification project timelines and proactively alert stakeholders to deviations or risks.
    o Coordinate the steps for third-party (vendors and non-vendors) due diligence and/or qualification activities as required.
    o Ensure oversight, completion, and management of third-party due diligence and qualification activities.
    o Engage and coordinate with stakeholders and third parties to gather required responses and materials for due diligence.
    o Identify and assess potential risks associated with third parties through the EPRM process and due diligence activities.
    o Provide support and coordination for the EPRM process.
  • Risk management: Provide support /contribute to the third-party Quality Risk Assessment activities (QRAs).
  • Collaborate with the different Novartis stakeholders and external Third Parties as needed: GMA Evidence Generation team, Legal, ESP Quality Assurance, Procurement, and other departments as needed.
  • Contribute/support to the continuous improvements of the global GMA TPM process.
  • Ensures compliance with all required SOPs and business guidance documents.

Requirements:

  • Degree in a life science or health care discipline.
  • Previous experience in clinical vendor management or similar role with focus on clinical research is a plus but not required.
  • Clinical Trial/Medical Affairs experience in a pharmaceutical company or a contract research organization is required.
  • Project management experience in clinical operations in a pharmaceutical company or a contract research organization. Emphasis on business, experience with clinical/medical affairs processes and activities and associated external services, with excellent understanding of study management.
  • Good knowledge of the regulatory requirements in Clinical Research and drug development:
    o In-depth knowledge of the international pharmaceutical product development process.
    o Experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities.
    o A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.
    o A broad understanding of Quality Management, GCP / GVP and Risk Management processes.
  • Understanding of procurement processes and Knowledge of clinical external suppliers landscape (CROs, Central Labs, specialty services, eCOA and new technologies…).
  • Experience and ability to manage/supervise third parties and external suppliers is a plus but not required.
  • Good understanding of clinical data systems/platforms and overall integration of clinical data system and processes.
  • Language proficiency: fluent written and spoken English knowledge.

Workload: 100% (40 hours per week)
Role type: Onsite
Estimated start date: February 2025

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here.

Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here.

Accommodation: If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.

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