R&D Supplier Governance Monitor

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Requirements:

• BA/BS/BSc in the sciences or RN
• 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical trial experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company).
• Experience at, or oversight of, technical suppliers (imaging and/or adjudication).
• Experience working in a global, matrix organization.
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines.
• Project management/project planning experience.
• Proficiency in anticipating and resolving problems.
• Experience writing and communicating clearly on scientific and clinical issues.
• Excellent interpersonal, organizational, supervisory skills.
• Professional collaboration and leadership skills.
• Experience in compliance, quality, and audit

Responsibilities:

• Monitoring the collection, processing, and analysis of data by Service Suppliers for Amgen sponsored clinical trials
• Monitoring and evaluating Supplier compliance and data quality
• Tracking corrective actions in relation to monitoring issues and audit findings; escalates as appropriate
• Developing professional relationships with service suppliers and with Amgen stakeholders
• Driving continuous improvement
• Communicating identified issues to key stakeholders at the supplier and at Amgen
• Facilitating and implementing supplier governance meetings, operating reviews, monitoring key performance indicators and perform issue management
• Build and maintain relationships with key internal and external partners, including study teams, functional leads, procurement, quality, compliance, and suppliers
• Support business functions with evaluation, selection, and startup of suppliers
• Ensure quality oversight of vendors though:
• Working with suppliers and internal customers (typically up to Director level) to identify, lead, raise and resolve issues related to supplier performance
• Measuring supplier performance and reporting performance feedback to internal partners and supplier