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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