Sr Project Mgr

Thousand Oaks, CA 91320

Posted: 09/20/2018 Employment Type: Contract Industry: Biotech Job Number: 4842

The Manager, Clinical Systems, 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 


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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