Sr. Study Manager

HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Sr. Clinical Trial Manager - Early Development (US-Remote)

What you will do
Lets do this. Lets change the world. In this vital role you will be a part of our Global Development Operations (GDO). You will be accountable for the implementation, management and reporting of Early Development (ED) clinical trials (phase 0 - 1b) and be a member of one or more cross-functional clinical study teams. These programs focus on the rapid development of emerging New Molecular Entities (NMEs) and require implementation of novel and highly flexible global operational strategies.
Sr. Clinical Trial Managers will work in varying therapeutic areas including hematology/oncology, cardiometabolic, inflammation and healthy volunteer.

Responsibilities:
Develop and lead, manage and co-ordinate the operational strategy, risk management, and overall implementation of clinical trials
Maintain the quality and scientific integrity of clinical trials
Lead the Clinical Study Team to drive effective decision making and encouraging innovative thinking
Contributes to the strategic scenario planning in clinical development plan
Develops and maintains study timeline and development of clinical protocol and informed consent
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 escalated by 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
Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
Support Global Clinical Program Management resource planning for assigned program(s)
Support continuous improvement initiatives in GCPM, ED, and GDO
Manages vendors and functional service providers (FSP)
Line Management of GCTMs / GECDMs

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Clinical professional we seek is an ambitious leader with these qualifications.

Basic Qualifications:
Doctorate degree or
Masters degree & 5 years of directly related experience or equivalent or
Bachelors degree & 7 years of directly related experience or equivalent or

Preferred Qualifications:
8+ years work experience in life sciences or medically related field
Minimum 5 years experience in leading global teams
Advanced degree in the scientific or healthcare discipline preferred
Experience conducting first in human trials and early development study strategy & management
Experience with innovative trial designs

What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply nowﾠfor a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.