**Purpose:** • Represents local functional management team within Global Study Operations Site Management (GSO-SM) • Maintains an effective collaborative partnership with all stakeholders and assures overall quality of work performed by CRO staff (eg CRAs, CTAs) in support of Amgen sponsored clinical trials • Leads and manages contract responsibilities for Amgen sponsored and investigator sponsored clinical trials. **Key activities:** • Performs sponsor oversight activities of FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials. • Collaborates closely with FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is deployed. • Supports FSP staff onboarding and training • Supervises staff involved in local site contracting and budget management, insurance and payment process • Manages Site Contracting and Budget Associate (SCBA) onboarding and training • Point of escalation for all stakeholders to support resolution of issues eg quality, staff turnover and performance concerns • Works with FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out • Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships • Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution • Organizes and leads the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable. • Involved in local and global site management and crossfunctional stakeholder collaboration • Actively participates in role forums including local and global functional and cross-functional initiatives **Basic qualifications:** • Master’s degree OR • BA/BS/BSc or qualified nurse (RN) • Minimum of 12 years of 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) **Preferred qualifications:** • Broad work experience working in life sciences or medically related field, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company • Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry • Experience in a project leadership role • Experience working with or for Functional Service Provider or Contract Research Organizations • Supervisory Experience & People managing • Knowledge of or work experience with QC department **Knowledge:** • Familiarity with advanced concepts of clinical research • Extensive knowledge of ICH/GCP regulations and guidelines • Strong knowledge of clinical trial operations • Understanding of Functional Service Provider operational model • Computer and system operation skills • Relevant therapeutic area education and training • Detailed understanding of customer service • Demonstrated ability to anticipate and resolve problems **Competencies:** • Demonstrated ability to work independently with minimal supervision • Ability to work effectively in a team/matrix environment on multiple projects • Excellence in relationship building • Ability to lead and influence in a positive manner • Leadership • Strong interpersonal skills • Excellent organizational and planning skills • Excellent oral and written communication • Language: Business English fluency • Attention to quality and detail • Ability to identify and resolve problems • Flexibility • Ability to write and present clearly using scientific and clinical issues terminology • Attention to quality planning and execution • Ability for critical thinking and thinking out of the box