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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 Employee Value Proposition:    
  • Chance to join fast paced dynamic team where the candidates where be challenged and have a direct positive impact on patients lives.
  • Based on performance there is a possibility of FTE opportunities if available.
  • 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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