Career CategoryClinical
Job DescriptionStudy Oversight Sr MgrWhat you will doLet'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 youWe 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
- Experience at, or oversight of, clinical research suppliers (CRO's, 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 usAs 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, we'll 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
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.
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