Amgen Work Values

Daily Duties at Amgen:

Guide Clinical Operations for a $45,000,000 - 300 subject Phase 3 Cardiovascular/Metabolic Familial Hypercholesterolemia Pediatric Trial at 44 sites in 21 countries. Function as the primary study contact during trial conduct including regular conferences and meetings with stakeholders. Direct the vendor selection, conduct negotiations, and issue requests for proposal. Ensure vendor statements of work are being followed. Author and/or contribute to and approve protocol amendments, study concept documents, ICFs and assents, and eCRFs. Hire, manage, train and develop study team members. Manage study budget including invoice review/approval and deliver financial forecasting. Provide support for SOP adherence and IVRS system questions. Proactively escalate performance related concerns to appropriate line management. Develop and manage team member transition plans. Guide Clinical Operations for a $35,000,000 - 150 subject Phase 3 Cardiovascular/Metabolic Heterozygous Familial Hypercholesterolemia Pediatric Trial at 32 sites in 14 countries. Function as the primary study contact during trial conduct including regular conferences and meetings with stakeholders. Direct the vendor selection, conduct negotiations, and issue requests for proposal. Ensure vendor statements of work are being followed. Author and/or contribute to and approve protocol amendments, study concept documents, ICFs and assents, and eCRFs. Hire, manage, train and develop study team members. Manage study budget including invoice review/approval and deliver financial forecasting. Provide support for SOP adherence and IVRS system questions. Proactively escalate performance related concerns to appropriate line management. Develop and manage team member transition plans.

What they like about Amgen:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

Pharmaceutical, CRO, Clinical Study Manager, Clinical Research, Dallas, Home-based, Cardiovascular, Endocrinology, Neurology, Gastroenterology, Rheumatology, Pediatrics, Genetic Disorders, Vendor Management, Author, Phase 4, Phase 3, Phase 2, Global, Leadership, Therapeutic area, Oversight, Financial Forecasting, Budget, monitoring, biotech

Skills

Document Management System: EDM Teams, Document Management System: eROOM, Document Management System: EPIC, Document Management System: ELARA, Remote Data Capture Systems: Oracle Clinical, Remote Data Capture Systems: Medidata RAVE, Remote Data Capture Systems: INET, Adverse Event Reporting Systems: ARISg, Adverse Event Reporting Systems: Argus, Adverse Event Reporting Systems: Oracle AERS, Analytics Systems: Spotfire , Analytics Systems: Clinrep, IVRS: Clinphone/Perceptive , IVRS: Almac

These are some of the questions we asked our climbers about their experiences with Amgen: