<h2><b>Career Category</b></h2>Clinical Development<h2></h2><h2><b>Job Description</b></h2><p><b>Purpose</b></p><p>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. Now we are hiring a <b>Clinical Trial Oversight Manager </b>in <b>Shanghai</b>.</p><p></p><h2><b><u>Responsibilities:</u></b></h2><ul><li>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</li><li>Provides support of clinical study execution</li><li>Provides GSO-SM functional area expertise and actively collaborates in a dynamic cross-functional environment</li><li>Oversight of the site contracting, budgeting and payment process</li><li>Line Manager of SCBAs</li></ul><h2></h2><h2><b><u>Key Activi</u></b><b><u>ties:</u></b></h2><ul><li>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.</li><li>Collaborates closely with SM-FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is</li><li>deployed.</li><li>Supports SM-FSP staff onboarding and training Supervises staff involved in local site contracting and budget management, insurance and payment process</li><li>Manages SCBA onboarding and training</li><li>Point of escalation for all stakeholders to support resolution of issues eg quality, staff turnover and performance concerns</li><li>Works with SM-FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management</li><li>from study start up to close-out</li><li>Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships</li><li>Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution</li><li>Organizes and leads the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.</li><li>Involved in local and global site management and cross-functional stakeholder collaboration</li><li>Actively participates in role forums including local and global functional and cross-functional initiatives</li></ul><p></p><h2><b><u>Qualifications</u></b></h2><ul><li>Doctorate degree OR Master’s degree OR BA/BS/BSc or qualified nurse (RN)</li><li>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)</li></ul><p>Preferred Qualifications</p><ul><li>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</li><li>Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry</li><li>Experience in a project leadership role</li><li>Experience working with or for Functional Service Provider or Contract Research Organizations</li><li>Supervisory Experience</li><li>Knowledge of or work experience with a biopharmaceutical GRDCA or QC department</li></ul><p></p><h2><b><u>Knowledge</u></b></h2><ul><li>Familiarity with advanced concepts of clinical research</li><li>Extensive knowledge of ICH/GCP regulations and guidelines</li><li>Strong knowledge of clinical trial operations</li><li>Understanding of Functional Service Provider operational model</li><li>Computer and system operation skills</li><li>Relevant therapeutic area education and training</li><li>Detailed understanding of customer service</li><li>Demonstrated ability to anticipate and resolve problems</li></ul><p></p><h2><b><u>Competencies</u></b></h2><ul><li>Demonstrated ability to work independently with minimal supervision</li><li>Ability to work effectively in a team/matrix environment on multiple projects</li><li>Excellence in relationship building</li><li>Ability to lead and influence in a positive manner Leadership</li><li>Strong interpersonal skills</li><li>Excellent organizational and planning skills</li><li>Excellent oral and written communication</li><li>Language: Business English fluency</li><li>Attention to quality and detail</li><li>Ability to identify and resolve problems</li><li>Flexibility</li><li>Ability to write and present clearly using scientific and clinical issues terminology</li><li>Attention to quality planning and execution</li><li>Ability for critical thinking and thinking out of the box</li></ul><p></p><p></p><p></p>.