Clinical Trial Oversight Manager
1 week ago
**Saudi Arabia - Riyadh**
**JOB ID**:
R-218102
**ADDITIONAL LOCATIONS**:
- Saudi Arabia - Riyadh
**WORK LOCATION TYPE**:
Field Worker
**DATE POSTED**:
Jun. 16, 2025
**CATEGORY**:
Clinical
**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 mínimal 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
-
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