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:

You give high priority to hiring firms with prestige. Market reputation and prestige of a firm may be determined through on-line research, and conversations with individuals working in your target industry. Note that firms "in the public eye" receive a great deal more critical publicity and attention than those operating with more anonymity. So as you assess your employment opportunities, be sure to seek out the positive aspects of the firm's reputation in addition to noting negative publicity the company may have received.

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: