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.
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
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"