Sr Project Mgr AFP

Location: Thousand Oaks, CA
Date Posted: 05-22-2017
Summary:
This position can be located in Thousand Oaks or San Francisco, CA -On-site no remote workers.
Ideal candidate has 4+ years in Clinical Trials, experience implementing clinical systems , and with clinical systems (IVRS preferable) experience.

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.

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

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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