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Clinical Trial Oversight Manager

Employer
Amgen
Location
Washington D.C., District of Columbia
Start date
Jun 11, 2024

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Clinical Trial Oversight Manager

Live

What you will do

Lets do this. Lets change the world. You will be the single point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, including the identification, escalation and resolution of quality and delivery issues.

  • Performs sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials.
  • Collaborates closely with SM-FSP Line Manager (FSP-LM) to ensure appropriate level of their staff oversight is deployed.
  • Supports SM-FSP staff onboarding and training
  • Point of escalation for all stakeholders to support resolution of issues eg quality, staff turnover and performance concerns
  • Works with SM-FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
  • Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
  • Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
  • Organizes and leads the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.
  • Involved in local and global site management and cross-functional stakeholder collaboration
  • Actively participates in role forums including local and global functional and cross-functional initiatives
Win

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 driven individual with these qualifications.

Basic Qualifications:
  • Doctorate degree OR
  • Masters degree & 3 years of clinical experience OR
  • Bachelors degree & 5 years of clinical experience OR
  • Associates degree & 10 years of clinical experience OR
  • High school diploma / GED & 12 years of clinical experience
Preferred Qualifications:
  • BA/BS/BSc in the sciences or RN
  • 7 years work experience in life science or medically related field
  • 4 years experience working in clinical site management (working on clinical trials at a biotech, pharmaceutical or CRO company)
  • Solid understanding of the Functional Service Provider Operational Model
  • Knowledge of or work experience with a biopharmaceutical GRDCA or QC department
Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

  • 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
Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your 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.

#obesity

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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