Clinical Vendor Project Manager

Vor 2 Tagen

Basel, Schweiz Coopers Group AG Vollzeit

**Clinical Vendor Project Manager**

For our phamraceutical client in Basel, we are looking for a Clinical Vendor Project Manager who will drive the third-party (vendor and non-vendors) due diligence and qualification activities

Start date: Immediately

Duration: 1 year

Location: Basel

**Responsibilities**:

- Drive the third-party (vendor and non-vendors) due diligence and/or qualification activities, as required:

- Ensure oversight, completion, and management of third-party due diligence activities/qualification as appropriate depending on the nature and type of third-party activities
- Accountable for quality and completeness of due diligence/qualifications and associated documentation in Third-Party Management (TPM) systems and tools
- Engage and coordinate with TPs, responses and materials/information needed to complete due diligence activities.
- Identify potential risks with third-parties from the TPRM process and due diligence activities
- Risk management: Provide support to the third-party governance and oversight process and ensure Quality Risk Assessments (QRAs) are properly completed and accurate for the different GMA activities (interventional trials, NIS, RWE, RCs and partnerships)
- Support External Relations Management Medical Affairs deviation management process by acting as Deviation Owner and leading the process of deviation investigation and documentation, following up on CAPA design and implementation.
- Provide support/coordinate the maintenance of the due diligence tool (TPIAT)
- Contribute/support to the continuous improvements of the global GMA TPM process: Lead or contribute as SME in the design, revision and implementation of standards and policies related to External Relations Management Medical Affairs.
- Support implementation of change management initiatives and training.
- Providing TPM expertise and training to operational teams and countries

**Experience**:

- Degree in a life science or health care discipline
- Previous experience in clinical vendor management or similar role with focus on clinical research
- Clinical Trial/Medical Affairs experience in a pharmaceutical company or a contract research organization is required.
- Experience in strategic negotiations, alliances, and 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:

- 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)

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