Sr. Project Manager # JN -112018-43174

Thousand Oaks, CA

Posted: 11/08/2018 Industry: Business Analyst / Project Manager Job Number: JN -112018-43174
Description:
  • The Manager, Clinical Systems - ETO will work with cross-functional teams responsible for executing 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 policies, procedures and guidelines

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

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 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
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