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Clinical Systems Manager

Thousand Oaks, CA
Description:
Please ask candidates these pre screening questions. Provide answer on resumes.
1. Have you experience analyzing IRT data through Tableau or other software?
2. Have you supported implementation of system-to-system data integrations through the SDLC (Software development lifecycle)?
3. On which IRT platforms do you have experience with?

Fully REMOTE
  • Shift - Monday - Friday, any time zone however west coast based in preferred but not required
  • Sit anywhere in the US
Successful Candidate:
  • Experience understanding how systems communicate with one another through integrations as they relate to IRT systems
  • Data analytics / Tableau experience a plus
  • IRT (Interactive response technologies) / RTSM (Randomization and Trial Supply Management) system experience required
  • Pharma or Biotech or supplier experience required; previous experience a plus
  • Must have experience designing or maintaining IRT systems for clinical trials
  • Negotiation with external vendors, management of projects and people, familiarity with documentation in a regulated environment
  • Clear communicator
  • Positive disposition
  • Used to a white glove role and able to support IRT users internally and externally.
  • Knows their stuff and can demonstrate through experience. Lead projects against tight timelines.
  • The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to:
  • Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to 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.

Basic Qualifications:
  • Doctorate Degree
  • Master's Degree and 2 years of IRT experience
  • Bachelor's Degree and 4-5 years of IRT experience, clinical experience
  • Associate's degree and 10 years of IRT experience
  • High school diploma/GED and 12 years of IRT experience

Preferred Qualifications:
  • 5+ years focused on IRT experience
  • 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

Top 3 Must Have Skill Sets:    
  • Real work experience outside of school environment
  • Technical expertise in IRT systems and data (Analyzing data, building studies, support)
  • Familiarity with documentation in a regulated environment
  • Management of projects and stakeholders
 
Pay Rate  between $74 - $85/Hr on W2 based on experience.
 
"This posting is for Contingent Worker, not an FTE"

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