Beschreibung
Scientific Project Management - 3rd Party Qualifications (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM
Main tasks:
- 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
- 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
- Stakeholder Collaboration
Main qualifications
- 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
- 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
- Good understanding of clinical data systems/platforms and overall integration of clinical data system and processes
- Language proficiency: fluent written and spoken English knowledge
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
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