Global Trial Manager

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

This is a full-time position. May telecommute. Supervises direct reports.

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.
• Manage study budget and timelines.
• Manage vendors to the required standards.

Requirements

• Master’s degree (or foreign equivalent) in Biotechnology, Biology, Project Management, or a related field and 3 years of experience in the job offered or in a trial-study-related occupation.
• Project management skills, including leading study-level planning of overall clinical operations 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, site operational or quality concerns, and budget or timeline variances.
• Implement and conduct clinical trials in accordance with sponsor procedures and ICH-GCP guidelines.

Pay

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

Benefits

• A comprehensive employee benefits package, including:
  • A Retirement and Savings Plan with generous company contributions.
  • Group medical, dental, and vision coverage.
  • Life and disability insurance.
  • Flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.