Sr Project Mgr AFP

Location: Thousand Oaks, CA
Date Posted: 01-10-2018
Day to Day Responsibilities:  
  • Lead and facilitate system requirements gathering meetings with clinical study teams and IVRS design PM
  • Design and oversee the development of study-specific IVRS 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:
This position can be located in Thousand Oaks or San Francisco, CA
The Clinical Data Management (CDM) Systems Manager will work with cross-functional teams responsible for executing Amgen clinical trials, as well as, Interactive Voice/Web Response Systems (IVRS) supplier and Project Managers to support the design, implementation and maintenance of outsourced IVRS systems. The role provides technical and project management oversight to ensure that the system designed for the study adheres to the study’s protocol, industry regulations / best practices, and Amgen policies, procedures and guidelines.

Basic Requirements:
Doctorate Degree
OR
Master's Degree & 3 years of Clinical experience
OR
Bachelor's Degree & 5 years of Clinical experience
OR
Associate's degree & 10 years of Clinical experience
OR
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 IVRS and eCOA
  • Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
  • PMP certification
  • 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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