Global Trial Manager

About the role

Join Amgen's mission to serve patients living with serious illnesses. As a Global Trial Manager, you'll help make a lasting impact on patients' lives as we research, manufacture, and deliver innovative medicines. Our award-winning culture is collaborative, innovative, and science based.

Responsibilities

• Monitor work productivity or quality to ensure compliance with standard operating procedures
• Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation
• Oversee resolution of audit findings to ensure accuracy, completeness, or proper usage of clinical systems and data
• Oversee the quality and scientific integrity of clinical operations for studies at a global level
• Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
• Lead the Clinical Study Team to drive effective decision making
• Plan and manage the reporting of clinical studies conducted by Global Development through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
• Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
• Management of study budget and timelines
• Management of vendors to the required standards
• May telecommute
• Supervises direct reports

Requirements

• Master's degree (or foreign equivalent) in Biotechnology, Biology, Project Management or a related field
• 3 years of experience in the job offered or in a Trial Study related occupation
• Exhibit project management skills including leading study level planning of the overall clinical operation and maintaining study timelines
• Experience with operational conduct of a study in startup, conduct, and close out phases, including but not limited to site identification, evaluation, selection, activation, and closeout
• Development and review of clinical study-related documents
• Vendor Management to ensure on time startup and delivery of services needed to conduct the clinical trial
• Operations of clinical trials including: Study Planning & Trial Start-Up, Site Management & Oversight, Patient Recruitment & Retention, Trial Conduct & Data Quality, and Trial Budget & Financial Management
• Resolving issues or risk mitigation for clinical trials including: slower projected enrollment, high rate of protocol deviations, safety concerns involving the investigational product, data quality problems, and site operational or quality concerns, budget or timeline variances
• Implement and conduct clinical trials in accordance with sponsor procedures and ICH-GCP guidelines

Pay

Full-Time position. The annual salary for this position in the U.S. is $185,806.00 per year.

Benefits

This position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation.