Design specifications for and implement tools/applications to support integrations between systems Data analysis of clinical trial operational data and its relationships with processes to support clinical trial performance management Integration of visual data views to inform the review and interpretation of information Support study team activities, operating reviews, and management requests through the delivery of information to support decision making Review of data quality activities to assure appropriate stewardship of data Model major business processes to drive a common understanding of business needs across stakeholder groups Develop plans, partner with suppliers, communicate progress and escalate issues ensuring effective stakeholder management Delegate tasks to assigned staff and/or contractors that support larger deliverables and projects Review and suggest improvements to guidance documents based on experience to ensure accurate representation of current processes Execute special projects and assignments Responsible For: Data analysis done in a rigorous manner through the use of application and analytical development methodologies suitable for a validated environment Delivering fit for purpose deliverables incorporating knowledge of Clinical Trial processes Ensuring appropriate documentation for areas of responsibility Developing best practice procedures and processes based on lessons learned Planning and execution of necessary activities to deliver Key Activities Data analysis of clinical trial operational data and its relationships with processes to support clinical trial performance management Integration of visual data views to inform the review and interpretation of information Support study team activities, operating reviews, and management requests through the delivery of information to support decision making Review of data quality activities to assure appropriate stewardship of data Model major business processes to drive a common understanding of business needs across stakeholder groups Develop plans, partner with suppliers, communicate progress and escalate issues ensuring effective stakeholder management Delegate tasks to assigned staff and/or contractors that support larger deliverables and projects Basic Qualifications: Doctorate degree OR Masters degree and2 years of clinical experience OR Bachelors degree and4 years of clinical experience OR Associates degree and10 years of clinical experience OR High school diploma / GED and12 years ofclinical experience Preferred Qualifications: BA/BS/BSc in the sciences or RN 5 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company) Previous management experience of direct reports Strong understanding of the concepts of clinical research and drug development Strong understanding and experience in the use of performance management techniques, measurement and visualization Strong understanding of principals of customer service as it applies to internal and external customers Advanced computer and system operation skills Continuous improvement principles and their application e.g., Six Sigma Understanding of project management software Good organizational and planning skills Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements Familiar with other Data Management systems (EDC, IVR, etc.) Join Us If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics.
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