Senior Global Trial Manager – Early Development & Late Development (Multiple Openings)

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. 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 world’s toughest diseases. With our 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.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Global Trial Manager – Early Development & Late Development (Multiple Openings)

What you will do

Let’s do this. Let’s change the world. In this vital role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP.

Sr Global Trial Managers will work in varying therapeutic areas including hematology/oncology, cardiometabolic, inflammation and healthy volunteer.

• Leads study level planning of the overall clinical operation results
• Develops late phase clinical operation strategy and contributes to strategic scenario planning in clinical development plan
• Develops and maintains study timeline and development of clinical protocols and informed consents
• Contributes to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials, safety and regulatory documents, and clinical study report, etc.
• Leads clinical study team to identify, evaluate and select clinical sites
• Handles the day-to-day operations of clinical trial at a global level and resolves issues called out by the local study team
• Maintains close collaboration with site investigators through regular and ad hoc investigator and site meetings, keeping investigators, often including key thought leaders, engaged to the study
• Trains study team members and/or sites to conduct the study
• Leads and coordinates Dose Level Review meetings, communicates decisions of the meetings, and operationalize Dose Level Review meeting outcomes
• Manages vendors and functional service providers (FSP)
• Line Management of Global Trial …