Position Details:
Job Title: Clinical Systems Manager
Location: Remote
Duration: 12 Months contract with possibility of extension
Job Summary:
1. Have you designed an IRT system based on clinical protocol?
2. Have you managed an IRT through SDLC (Software development lifecycle)?
3. On what IRT platforms do you have experience designing and managing a clinical study IRT system?
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
IRT (Interactive response technologies) / RTSM (Randomization and Trial Supply Management) system experience required
Pharma or Biotech or IRT supplier experience required
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
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
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