Clinical Trial Oversight Manager

Career Category

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 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
Masters 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