Study Oversight Sr Mgr

Career Category

Clinical Development

Job Description

Accountabilities

• 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

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 and 2 years of clinical execution experience OR
• Master’s degree and 6 years of clinical execution experience OR
• Bachelor’s degree and 8 years of clinical execution experience OR
• Associate’s degree and 10 years of clinical execution experience OR
• High school diploma / GED and 12 years of clinical execution experience
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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
• 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

Competencies
• Experience with 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
• Ability to 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
• Proficient in 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
• Ability to 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.

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