Sobre esta vaga de Study Oversight Manager na Amgen
Amgen · Presencial · Romania - Bucharest
Career Category
ClinicalJob Description
The Study Oversight Manager (SOM) leads and manages the resourcing, collaboration, and performance of FSP suppliers at the country level. The role serves as the main contact and escalation point for suppliers, supporting clinical study execution and ensuring efficient, high-quality clinical trial results.
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.
• 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.
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.
• 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
• 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.
.• 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.
Salary Range
289,156.40 RON - 391,211.60 RON
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