Clinical Systems Manager

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"