Vendor & Third Party Management Clinical Project Manager

vor 16 Stunden

Basel, Schweiz Hays Vollzeit
Vendor & Third Party Management Clinical Project Manager

For our client, a renowned pharmaceutical company in Basel, we are currently looking for a Vendor & Third Party Management Clinical Project Manager.

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.

General information:

  • Start: asap
  • End: 12 months, extension possible based on workload
  • Location: Basel campus onsite

Main activities and key responsibilities:

  • Act as the main support for Vendor and Third-Party Management (V&TPM).
  • Coordinate V&TPM activities and responsibilities with Evidence Generation study teams (Study Execution + Evidence Generation).
  • 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).
  • Oversee the end-to-end process, including liaison with Legal, qualification, RFP, contracting, and PO management.
  • Interface with stakeholders and the company's functions, providing inputs and updates as needed.
  • Manage qualification project timelines and proactively alert stakeholders to deviations or risks.
  • Coordinate the steps for third-party (vendors and non-vendors) due diligence and/or qualification activities as required.
  • Ensure oversight, completion, and management of third-party due diligence and qualification activities.
  • Engage and coordinate with stakeholders and third parties to gather required responses and materials for due diligence.
  • Identify and assess potential risks associated with third parties through the EPRM process and due diligence activities.
  • Provide support and coordination for the EPRM process.
  • Provide support/contribute to the third-party Quality Risk Assessment activities (QRAs).
  • Collaborate with the company's different 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.
  • Ensure compliance with all required SOPs and business guidance documents.

Background: Education and Experience:

  • 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.
  • In-depth knowledge of the international pharmaceutical product development process.
  • Experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities.
  • A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.
  • 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.

The deadline for the submission of the applications is on Monday, January 27th at 10.00.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Management, Strategy/Planning, and Science
Industries
  • Pharmaceutical Manufacturing
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