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About the Role

Accountable for managing all FSP resources (CRA, CTA, LSOM) to ensure quality, efficiency, and adherence to compliance standards. Serve as the secondary contact and escalation point for all FSP supplier-related concerns within the country. Lead both internal and external governance meetings to monitor supplier performance in relation to oversight metrics and thresholds. Facilitate effective cross-functional collaboration to ensure smooth trial execution and timely resolution of issues. Promote continuous improvement efforts in site and study operations to enhance supplier engagement and optimize trial delivery.

Responsibilities

Mentor, train, and support the professional development of SOM Mgr
Serve as the point of contact for FSP supplier(s) resource and capacity management, portfolio planning and prioritization from study startup to close-out at the country level
Ensures oversight of supplier performance (e.g., tracking against metrics, assuring overall quality of work performed by FSP staff)
Identification, escalation and resolution of quality and trial delivery issues
Collaborate with LSOMs Sn Mgs and/or LSOM AD to ensure appropriate level of staff oversight, maintaining quality throughout Amgen clinical trials (e.g., occasional on-site quality visits)
Ensure effective collaboration between SOM Mgs, driving consistent communication with FSPs, sites and alignment with global strategies
Escalate issues to the County-Hub Head GSSO
Aggregate & communicate country-wide issues through consolidating input from FSPs to provide country-aggregated view on FSP trends and challenges to senior management
Oversee management of FSP supplier performance covering study milestones achievement and quality targets
Supports inspection readiness
Supports local country site level audits and regulatory inspections when applicable
Supports maintenance of Amgen investigator site relationships in country
Participates in cross functional task force / process improvement groups

Requirements

Doctorate degree and 2 years of clinical execution experience
Master’s degree and 6 years of clinical execution experience
Bachelor’s degree and 8 years of clinical execution experience
Associate’s degree and 10 years of clinical execution experience
High school diploma / GED and 12 years of clinical execution experience
Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience managing multiple teams / direct reports across multiple clinical functions / trials
Experience at, or oversight of, clinical research suppliers (CRO’s, central labs, imaging suppliers, etc.)
Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials

Skills

Leading, developing and training teams related to clinical trial materials (e.eg., CRAs, site staff, and cross-functional teams) to ensure alignment with study protocols, regulatory requirements, and best practices
Manage, mentor, and develop professionals and support staff across functions, while fostering collaboration across internal and external teams for trial success
Clear understanding of country level regulations and compliance for clinical trials, keeping up to date on clinical trial that may impacting managing ethics submissions, study start-up processes, and site inspection readiness at a country-level
Ensuring site preparedness and smooth execution across all study phases by supporting site initiation visits (SIVs), recruitment calls, and adherence to study timelines
Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally
Identify operational risks based on protocol design and implement innovative mitigation strategies
Identify and manage study issues, communicating and/or escalating appropriately
Understand country-level dynamics impacting patient enrollment, patient safety compliance, safety notifications, and resolving site-related issues
Demonstrates ability for end-to-end management of study deliverables, budgets, timelines, and performance metrics (KPIs) to optimize trial execution
Understanding of EDC systems, data integrity, and query resolution
Collaboration with data management and biostatistics teams
Navigates diverse regulatory, cultural, and operational environments
Builds strong relationships across geographies and time zones

Experience Level

2 years of clinical execution experience
6 years of clinical execution experience
8 years of clinical execution experience
10 years of clinical execution experience
12 years of clinical execution experience
2 years experience directly managing people and/or leadership experience
7 years work experience in life sciences or medically related field
4 years of biopharmaceutical clinical research experience
Experience managing multiple teams / direct reports
Experience at, or oversight of, clinical research suppliers
Experience managing clinical operations across relevant geography / region

Education Level

Doctorate degree
Master’s degree
Bachelor’s degree
Associate’s degree
High school diploma / GED

About the Company

Amgen clinical trials
Amgen investigator site relationships