Manager, Clinical Systems (Irt)

Advanced Bio-Logic Solutions Corp Thousand Oaks , CA 91360

Posted 2 months ago

Top 3 Must Have Skill Sets:
  • 2-3 years of experience specifically in IRT/IVRS/RTSM/IXRS - either at a vendor, biotech or Pharma company. When discussing these technologies with the candidates, they must have been part of a build or project managed the build. This is an important skill set that the managers do not have time to train on so they must be very skilled in this area. Candidates without this skill set/experience will be rejected. (Interactive response technology)
  • This person will most likely come from a background in Business Analysis, Clinical Supply, Project Management (2-3 years of experience)
  • Clinical Trial experience (2-3 years of experience)
Summary:The Manager, Clinical Systems (IRT) will work with a cross-functional 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 study-specific IRT technical documents
  • Document issues and risks, and implement mitigation plans in partnership with study team and technology supplier PM
  • Identify and track study-related technical issues to resolution
  • Closely manage project-related timelines and associated activities
Basic Qualifications:Doctorate DegreeORMaster's Degree and 3 years of IRT experienceORBachelor's Degree and 5 years of IRT experienceORAssociate degree and 10 years of IRT experienceORHigh school diploma/GED and 12 years of IRT experiencePreferred Qualifications:
  • 5+ years of IRT experience and / or a clinical supply chain discipline (supply chain management, distribution, packaging, labeling, etc.)
  • 4+ years of experience in clinical operations 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
  • Bachelors Degree in life science, computer science, engineering, business or related discipline
  • Detail-oriented and able to manage many projects simultaneously
  • Excellent documentation and communication skills
  • Meeting management and facilitation skills
  • Supplier 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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Manager, Clinical Systems (Irt)

Advanced Bio-Logic Solutions Corp