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Sr Project Mgr AFP

Thousand Oaks, CA
Top 3 Must Have Skill Sets
  • 2-3 years of experience specifically in IRT/IVRS/RTSM/IXRS - either at a vendor, biotech or Pharma company.
  • This person will most likely come from a background in Business Analysis, Clinical Supply, Project Management
  •  lastly this person must have clinical experience
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
  • 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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