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 crossfunctional
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 crossfunctional
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 bo
