Study Oversight Manager

Responsibilities
Act as the main liaison for FSP supplier(s) regarding resource and capacity management portfolio planning and prioritization throughout the study lifecycle from startup to close-out.
Facilitate onboarding and training for FSP roles including CRAs and CTAs.
Monitor supplier performance by tracking metrics and ensuring the overall quality of work delivered byFSP staff.
Identify escalate and resolve issues related to quality and delivery.
Work closely with LSOMs to provide appropriate staff oversight and uphold quality standards acrossAmgen clinical trials including occasional on-site quality visits.
Promote effective collaboration between CRA and CTA roles and other country-specific positions tomaintain consistent communication with sites and alignment with global strategies.
Collect and communicate country-wide concerns by consolidating feedback from FSPs offering seniormanagement an aggregated view of FSP trends and challenges.
Manage and oversee FSP supplier performance in relation to study milestones and quality objectives.
Support inspection readiness including local country and site-level audits as well as regulatoryinspections when necessary.
Assist in maintaining relationships with Amgen investigators within the country.
Participate in cross-functional task forces and process improvement initiatives.

Minimum Requirements
Doctorate degree OR
Masters degree and 2 years of clinical execution experience OR
Bachelors degree and 4 years of clinical execution experience
Associates degree and 8 years of clinical execution experience OR
High school diploma / GED and 10 years of clinical execution experience
Work experience in life sciences or medically related field including biopharmaceuticalclinical research experience (clinical research obtained working on clinical trials in a biotechpharmaceutical or CRO company or other relevant clinical setting).
In addition to meeting at least one of the above requirements you must have experiencedirectly managing people and/or leadership experience leading teams projects programsor directing the allocation or resources. Your managerial experience may run concurrentlywith the required technical experience referenced above.

5 years work experience in life sciences or medically related field including 3 years ofbiopharmaceutical clinical research experience obtained working on clinical trials in abiotech pharmaceutical or CRO company.
Experience at or oversight of clinical research suppliers (CROs central labs imagingsuppliers etc.). Experience as a CRA CTA and/or Clinical/Regional Manager in thebiopharmaceutical industry.
Experience managing and supervising clinical trial staff across multiple studies.