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Clinical Systems Manager

Thousand Oaks, CA
“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:    
  • Negotiation with external vendors, management of people and projects, familiarity with documentation in a regulated environment
Day to Day Responsibilities:    
The Manager, Clinical Systems (IRT) will work with a crossfunctional team of internal stakeholders (including, but not limited to, Clinical Study Management, Supply Chainand Data Management functions) and technology suppliersto support the implementation and maintenance of interactive response technology (IRT)solutions to support a clinical trial. The Manager, Clinical Systems (IRT)will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.

Responsibilities:
Serve as the champion and consultant for most efficient and effective IRT design as needed per study protocol
Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts
Design and oversee the development of studyspecific IRT technical documents
Document issues and risks, and implement mitigation plans in partnership with study team and technology supplier PM
Identify and track studyrelated technical issues to resolution
Closely manage projectrelated timelines and associated activities

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

Preferred Qualifications:
  • 5+ years ofIRT experience and / or a clinical supply chain discipline (supply chain management, distribution, packaging, labeling, etc.)
  • 4+ years of experience in clinical operationsor 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
  • Bachelor’s Degree in life science, computer science, engineering, business or related discipline
  • Detailoriented and able to manage many projects simultaneously
  • Excellent documentation and communication skills
  • Meeting management and facilitation skills
  • Suppliermanagement experience
  • Excellent time management and organization skills in a timelinedriven environment
  • Sound problem resolution, judgment, and decisionmaking abilities
  • Work well in a teambased environment with minimal supervision

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

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