Clinical Trial Oversight Manager

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

Preferred Qualifications

CRO company, or other relevant clinical setting)

• 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