Title: Clinical Systems Manager
Duration: 12 months
Location: Fully REMOTE (Sit anywhere in the US)
Shift - Monday - Friday, West Coast candidate preferred
 
Please ask candidates these prescreening questions. Provide answers on resumes.
1. Have you designed an IRT system based on a 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?
 
Top 3 Must-Have Skill Sets:   

• Technical expertise in IRT systems
• Management of projects and stakeholders
• Comfort managing documentation in a regulated environment

 
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 thorough experience. Lead projects against tight timelines.

 
Summary:
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.
 
Day-to-Day Responsibilities:  

• Serve as the champion and consultant for the most efficient and effective IRT design as needed per study protocol.
• Lead and facilitate system requirements gathering meetings with clinical study teams and the 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 the study team and technology supplier PM.
• Identify and track study-related technical issues to resolution.
• Closely manage project-related timelines and associated activities.

 
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

 
Possible Extension: Yes
Red Flags: NA
Interview Process: Video call through MS Teams, First round 1 on 1, second round panel interview. 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $71.00/hr.