Study Oversight Senior Manager

BioSpace; Washington (District of Columbia); Hybrid; USD 167,000 - 226,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Stock-based incentives

Flexible work arrangements

Paid time off

Job summary

Amgen seeks a Study Oversight Senior Manager to lead all country-level FSP resources (CRA, CTA, LSOM) ensuring quality, efficiency, and compliance. You will serve as the secondary contact for country-level FSP supplier concerns and drive strategic staff oversight across trials.

The role requires strong leadership in clinical execution with 2+ years of direct people management, and a track record in coordinating cross-functional teams, supplier performance, and regulatory readiness.

Qualifications

• Doctorate/Masters/Bachelors/Associates/High school diploma with substantial clinical execution experience.
• Minimum of 2 years of direct people management or leadership experience.

Responsibilities

• Mentor, train, and develop SOM Mgrs and staff.
• Oversee FSP supplier resource/capacity management and portfolio planning.
• Monitor supplier performance and quality against metrics.
• Identify and resolve quality and trial-delivery issues.
• Collaborate with LSOMs Sn Mgs and LSOM AD for staff oversight.
• Ensure cross-functional communication with FSPs, sites, and global strategies.
• Escalate issues to County-Hub Head GSSO.
• Summarize country-wide FSP trends for senior management.
• Oversee milestone delivery and quality targets for FSPs.
• Support inspection readiness and regulatory site audits when applicable.
• Maintain investigator site relationships in country.

Skills

Leadership experience

People management

Clinical research coordination

Regulatory knowledge

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma / GED

Job description

Study Oversight Sr Mgr

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What You Will Do

Lets do this. Lets 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
• Masters degree and 6 years of clinical execution experience OR
• Bachelors degree and 8 years of clinical execution experience OR
• Associates 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
• Experience at, or oversight of, clinical research suppliers (CROs, central labs, imaging suppliers, etc.)
• Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials

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, well support your journey every step of the way.

The annual base salary range for this opportunity in the U.S. is $167,187-$226,194.

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 Opportunities That May Include

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.

careers.amgen.com