Career Category

Clinical

Job Description

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

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)
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

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