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Sr Project Mgr AFP

Thousand Oaks, CA
Day to Day Responsibilities:    
  • Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts
  • Design and oversee the development of study-specific IRT technical documents
  • Document issues and risks, and implement mitigation plans in partnership with study team and vendor PM
  • Identify and track study-related technical issues to resolution
  • Closely manage project-related timelines and associated activities
Summary:
  • The Manager, Clinical Systems | ETO will work with cross-functional teams responsible for executing Amgen clinical trials, as well as, Interactive Response Technology (IRT) suppliers and Project Managers to support the design, implementation and maintenance of outsourced IRT systems. 
  • The role provides technical requirements consultation and project management oversight to ensure that the IRT designed for the study adheres to the study’s protocol, industry regulations / best practices, and Amgen policies, procedures and guidelines.

Basic Requirements: 
Doctorate Degree 
Master's Degree & 3 years of Clinical experience 
Bachelor's Degree & 5 years of Clinical experience 
Associate's degree & 10 years of Clinical experience 
High school diploma/GED & 12 years of Clinical experience 

Preferred Requirements: 
  • Bachelor’s Degree in life science, computer science, engineering, business or related discipline
  • 4+ years of experience in clinical operations, clinical supply chain or clinical systems management
  • Experience implementing clinical systems, such as IRT and eCOA
  • Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
  • Detail-oriented and able to manage many projects simultaneously
  • Excellent documentation and communication skills
  • Meeting management and facilitation skills
  • Vendor management experience
  • Excellent time management and organization skills in a timeline-driven environment
  • Sound problem resolution, judgment, and decision-making abilities
  • Work well in a team-based environment with minimal supervision
"This posting is for Contingent Worker, not an FTE"
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