Description
**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:**
+ 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
**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
