Clinical Trial Oversight Manager

1 week ago


Riyadh, Saudi Arabia Amgen Full time

**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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