Description:
Note:

• Fully remote
• Shift - Monday - Friday, any time zone
• Sit anywhere in the US

Please ask candidates these prescreening questions. Provide answer on resumes

• Have you designed an IRT system based on clinical protocol?
• Have you managed an IRT through SDLC (Software development lifecycle)?
• On what IRT platforms do you have experience designing and managing a clinical study?

Shift - Monday - Friday, any time zone
Sit anywhere in the US

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.

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

Basic Qualifications:

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

Top 3 Must Have Skill Sets:

• Technical expertise in IRT systems,
• management of projects and stakeholders,
• comfortable managing documentation in a regulated environment

Day to Day 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

Pay Rate  between $74 - $85/Hr on W2 based on experience.

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