Job description
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. .