Study Oversight Manager

Accountabilities
The Study Oversight Manager (SOM) is responsible for leading and managing the resourcing
collaboration and performance of FSP suppliers at the country level.
Acts as the main contact and escalation point for FSP suppliers working cross-functionally to support
clinical study execution and ensure efficient high-quality clinical trial results.
Works together with LSOMs to oversee key country-level suppliers involved in study delivery.

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 by
FSP staff.
Identify escalate and resolve issues related to quality and delivery.
Work closely with LSOMs to provide appropriate staff oversight and uphold quality standards across
Amgen clinical trials including occasional on-site quality visits.
Promote effective collaboration between CRA and CTA roles and other country-specific positions to
maintain consistent communication with sites and alignment with global strategies.
Collect and communicate country-wide concerns by consolidating feedback from FSPs offering senior
management 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 regulatory
inspections when necessary.
Assist in maintaining relationships with Amgen investigators within the country.
Participate in cross-functional task forces and process improvement initiatives.

Qualifications
Describe the knowledge and skills necessary to perform the duties of this role. Include a
combination of education experience knowledge or the equivalent
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 biopharmaceutical
clinical research experience (clinical research obtained working on clinical trials in a biotech
pharmaceutical or CRO company or other relevant clinical setting)
In addition to meeting at least one of the above requirements you must have 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 Requirements (based off CTOM)
5 years work experience in life sciences or medically related field including 3 years of
biopharmaceutical clinical research experience obtained working on clinical trials in a
biotech pharmaceutical or CRO company
Experience at or oversight of clinical research suppliers (CROs central labs imaging
suppliers etc.)Experience as a CRA CTA and/or Clinical/Regional Manager in the
biopharmaceutical industry
Experience managing and supervising clinical trial staff across multiple studies

Competencies
Demonstrates expertise in identifying site-level challenges applying data-driven strategies
and implementing corrective actions to optimize trial performance
Experience supporting change management initiatives including updating of documentation
and processes
Skilled in planning and implementation of country level operational plan enhancing
compliance and driving continuous improvement initiatives for efficient and effective study
execution
Ability to recognize highlight and resolve issues. Demonstrates curiosity and willingness to take
on new tasks.
Ability to support processes around site preparedness and smooth trial execution across all
study phases and end-to-end activities
Experience with overseeing suppliers
Commitment to quality trial execution risk identification and risk management and audit
readiness
Open-mindedness towards skill development and active participation in internal training to
build knowledge of clinical trial processes.
Working knowledge of CTMS eTMF EDC and Microsoft Office tools. Ability to maintain
accurate and timely data entry. Skilled in managing clinical trial data flow investigator
documentation and protocol adherence while ensuring regulatory compliance
Understands importance of accuracy in documentation data tracking and compliance
checks. Identifies discrepancies and escalates appropriately.
Understanding of the clinical and pharmaceutical drug development process and clinical trial
execution principles

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