Study Oversight Senior Manager

Career Category
Clinical 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.
Study Oversight Sr Mgr
What you will do

Let’s do this. Let’s change the world. You will be accountable for managing all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and adherence to compliance standards. As well as serve as the secondary contact and escalation point for all FSP supplier-related concerns within the country.
Responsibilities:

Mentor, train, and support the professional development of SOM Mgr

• Serve as the point of contact for FSP supplier(s) resource and capacity management, portfolio planning

and prioritization from study startup to close-out at the country level

• Ensures oversight of supplier performance (e.g., tracking against metrics, assuring overall quality of work
performed by FSP staff)

• Identification, escalation and resolution of quality and trial delivery issues

• Collaborate with LSOMs Sn Mgs and/or LSOM AD to ensure appropriate level of staff oversight,

maintaining quality throughout Amgen clinical trials (e.g., occasional on-site quality visits)

• Ensure effective collaboration between SOM Mgs, driving consistent communication with FSPs, sites and
alignment with global strategies

• Escalate issues to the County-Hub Head GSSO

• Aggregate & communicate country-wide issues through consolidating input from FSPs to provide

country-aggregated view on FSP trends and challenges to senior management

• Oversee management of FSP supplier performance covering study milestones achievement and quality
targets
• Supports inspection readiness

• Supports local country site level audits and regulatory inspections when applicable

• Supports maintenance of Amgen investigator site relationships in country

• Participates in cross functional task force / process improvement groups
What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.
Basic Qualifications:

- Doctorate degree and 2 years of clinical execution experience OR

- Master’s degree and 6 years of clinical execution experience OR

- Bachelor’s degree and 8 years of clinical execution experience OR

- Associate’s degree and 10 years of clinical execution experience OR

- High school diploma / GED and 12 years of clinical execution experience

- In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

- 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

- Experience managing multiple teams / direct reports across multiple clinical functions / trials

- Expe