Clinical Trial Oversight Manager

Amgen Inc; Saudi Arabia; On-site; USD 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company in Saudi Arabia seeks a Clinical Trial Manager to oversee vendor operations and manage clinical trials. The role involves ensuring trial quality, collaborating across teams, and requires advanced qualifications in life sciences. Applicants should possess extensive clinical research experience and strong leadership skills to succeed in a dynamic environment.

Qualifications

• Experience in biopharmaceutical clinical research.
• Understanding of ICH/GCP regulations and clinical trial operations.
• Familiarity with Functional Service Providers.

Responsibilities

• Primary point of contact for FSP vendor(s).
• Oversight of site contracting and budget management.
• Supports inspection readiness and audit preparations.

Skills

Leadership

Interpersonal Skills

Communication

Problem Solving

Education

Doctorate degree

Master’s degree

BA/BS/BSc or qualified nurse (RN)

Job description

Career CategoryClinicalJob 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

.