Senior Study Oversight Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee all FSP resources (CRA, CTA, LSOM) to guarantee quality, efficiency, and compliance with standards.

• Act as the secondary contact and escalation point for any FSP supplier-related issues within the country.

• Guide, train, and facilitate the professional growth of SOM Managers.

• Manage FSP supplier resources and capacity, focusing on portfolio planning and prioritization from study initiation to closure at the country level.

• Supervise supplier performance, which includes tracking metrics and ensuring the quality of FSP staff's work.

• Identify, escalate, and address quality and trial delivery challenges.

• Collaborate with LSOMs Senior Managers and/or LSOM Associate Director to uphold quality throughout Amgen clinical trials, including occasional on-site quality assessments.

• Ensure effective collaboration between SOM Managers and maintain consistent communication with FSPs and sites.

• Escalate issues to the Country-Hub Head GSSO.

• Compile and communicate country-wide FSP trends and challenges to senior management.

• Monitor FSP supplier performance against study milestones and quality objectives.

• Assist in preparation for inspections, local country site-level audits, and regulatory inspections.

• Support the maintenance of Amgen investigator site relationships within the country.

• Engage in cross-functional task forces and process improvement initiatives.

⛳️ Requirements

• Doctorate degree with 2 years of clinical execution experience, OR a Master’s degree with 6 years of clinical execution experience, OR a Bachelor’s degree with 8 years of clinical execution experience, OR an Associate’s degree with 10 years of clinical execution experience, OR a High school diploma/GED with 12 years of clinical execution experience.

• At least 2 years of experience in directly managing personnel and/or leadership experience in guiding teams, projects, programs, or directing resource allocation.

• A minimum of 7 years of work experience in life sciences or a medically related field (preferred).

• At least 4 years of biopharmaceutical clinical research experience acquired through working on clinical trials in a biotech, pharmaceutical, or CRO company (preferred).

• Experience in managing multiple teams or direct reports across various clinical functions or trials (preferred).

• Familiarity with clinical research suppliers such as CROs, central labs, and imaging suppliers (preferred).

• Experience overseeing clinical operations across relevant geography/region, including a strong understanding of local regulatory requirements related to global clinical trials (preferred).

🏝️ Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans and bi-annual company-wide shutdowns.

• Flexible work models, including remote work arrangements where feasible.

• Career development opportunities.

• Work/life balance.

• Financial plans with options to save towards retirement or other goals.