Clinical Systems Manager- (Irt) Interactive Response Technologies-Remote (Jp9917)

Job Title: Clinical Systems Manager- (IRT) Interactive response technologies-remote (JP9917)
Location: Utah84044
Employment Type: Contract
Business Unit: CSAR Global Systems - IRT
Duration: 12 months with likely extensions
Job posting date:3/11/2022
Note: Remote
3 Key Consulting is hiring a Clinical Systems Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:

• IRT - Interactive response technologies
• Pharma or Biotech or supplier experience required
• Must have experience designing or maintaining IRT systems for clinical trials
• 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 OR
• Master's Degree and 3 years of IRT experience OR
• Bachelor's Degree and 5 years of IRT experience OR
• Associate's degree and 10 years of IRT experience OR
• High school diploma/GED and 12 years of IRT experience
  Preferred Qualifications:
• 5+ years of 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 Must have Skill Sets:
IRT experience including negotiation with external vendors, management of projects and people, familiarity with 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

Interview Process:
Video call through WebEx
We invite qualified candidates to sendyour resume toresumes@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this position, please feel free to look at other positions on our websitewww.3keyconsulting.com. You are welcome to also sharethis posting withanyone you think might be interested in applying for this role.