**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 SM-FSP staff (eg CRAs, CTAs) in support of Amgen sponsored clinical trials + Leads and manages contract responsibilities for Amgen sponsored and investigator sponsored clinical trials. **Responsibilities** + Primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues + Provides support of clinical study execution + Provides GSO-SM functional area expertise and actively collaborates in a dynamic cross-functional environment + Oversight of the site contracting, budgeting and payment process + Line Manager of SCBAs **Key activities include but are not limited to** + Performs sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials. + Collaborates closely with SM-FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is deployed. + Supports SM-FSP staff onboarding and training + Supervises staff involved in local site contracting and budget management, insurance and payment process + Manages SCBA onboarding and training + Point of escalation for all stakeholders to support resolution of issues eg quality, staff turnover and performance concerns + Works with SM-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 cross-functional stakeholder collaboration + Actively participates in role forums including local and global functional and cross-functional initiatives **Key Relationships: (excluding Direct Line relationships)** + SM-FSP Management + Local Operating Country Staff + Global Clinical Program Management + R&D Compliance and Audit + Global Development Operations Stakeholders + Investigator Site Staff + Global Supplier Governance + Innovation Planning & Platform Services **Decision Making Authority:** + Financial sign off within grade parameters + Risk mitigation, issue management and escalations + Hiring and performance management where applicable **Outputs:** + Reporting on quality (e.g., Site Quality Visits (SQV), monthly line manager reporting) and delivery and adherence to Quality Oversight Plan and country timelines and commitments. + Key performance Indicator (KPI) and scorecard review + Resource, planning and capacity management + Process analysis, improvement and global alignment. **Qualifications** **Basic qualifications:** + Doctorate degree OR + Master’s degree OR + BA/BS/BSc or qualified nurse (RN) + 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 + Knowledge of or work experience with a biopharmaceutical GRDCA or 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