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"