Scientific Project Management - 3rd Party Qualifications (m/f/d)

Ihre Aufgaben:
• 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

Ihre Qualifikationen:
• 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

Ihre Vorteile:
• A very renowned company

Projektdauer: 12 MM





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