Sr Project Mgr

Thousand Oaks, CA 91320 | Contract

Post Date: 08/03/2018 Job ID: 4577 Industry: Biotech

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. 


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 
Master' s Degree & 3 years of Clinical experience 
Bachelor' s Degree & 5 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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