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Clinical Systems Manager

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    

eCOA, Project Management, Clinical Trials

Day to Day Responsibilities:    

Support the Clinical Study teams in deploying eCOA solution leveraging external vendors

Job Details: 

The electronic Clinical Outcomes Assessments (eCOA) Technical Specialist will work with a cross functional team of Clinical representatives to support the design, implementation and maintenance of outsourced eCOA systems to support clinical trials. The individual within this role will provide technical oversight to ensure that the study specific eCOA systems adheres to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.

Key Responsibilities include:
  • Accountable for quality delivery and competencies within the XXXX service area
  • Oversee study level system requirements meetings with XXXX vendors and internal stakeholders
  • Assist in the design and development of study specific technical documents
  • Support the internal team in managing project related timelines and associated activities
  • Partner with data management (DM) to define the requirements for data transfers
  • Work with external resources to manage the creation and execution of user acceptance tests
  • Identify and track study-related technical issues to resolution
  • Provide a supportive framework for continuous process and quality improvements

Basic Qualifications:

Doctorate Degree OR
Master's Degree and 3 years of Clinical experience OR
Bachelor's Degree and 5 years of Clinical experience OR
Associate degree and 10 years of Clinical experience OR
High school diploma/GED and 12 years of Clinical experience

Preferred Qualifications:
  • Bachelor’s Degree in life science, computer science, engineering, business or related discipline
  • 4+ years of experience in clinical development
  • Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry
  • Knowledgeable in Good Clinical Practices, and FDA regulations necessary
  • Project management and technical expertise, attention to detail, and excellent documentation and communication skills
  • PMP
  • Previous vendor management experience
  • Excellent time management and organization skills
  • Have sound problem resolution, judgment, and decision-making abilities
  • Be able to work well in a team-based environment with minimal supervision

"This posting is for Contingent Worker, not an FTE"

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