Clinical Trial Oversight Manager

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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

Let’s do this. Let’s 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
• Master’s degree & 3 years of clinical experience OR
• Bachelor’s degree & 5 years of clinical experience OR
• Associate’s 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 …