Study Oversight Manager

Clinical Development

Job Description 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

• Line manager of the local contract manager team (SCBA team)
• 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
• Master’s degree and 2 years of clinical execution experience OR
• Bachelor’s degree and 4 years of clinical execution experience
• Associate’s 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 (CRO’s, 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"
• Fluency in a Scandinavian language is an advantage

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

For union related matters, please contact: unionen@amgen.com

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