Senior Global Trial Manager

Career Category

Job Description

oin 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 Managers (GTMs) and Local Trial Managers (LTMs)(study dependent).

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Sr. Manager with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of clinical research experience or
• Master’s degree and 6 years of clinical research experience or
• Bachelor’s degree and 8 years of clinical research experience or
• Associate’s degree and 10 years of clinical research experience or
• High school diploma / GED and 12 years of clinical research experience

Preferred Qualifications:

• Bachelor’s Degree or equivalent required (scientific or healthcare discipline preferred).
• 7+years of experience of clinical research and study management
• Experience in clinical program management
• Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programs

Offered Salary Range: $147,676 - $173,028

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportuni