IRT Manager

Advanced Bio-Logic Solutions Corp; Thousand Oaks (CA); On-site; USD 110,000 - 170,000; Part time

Job summary

Advanced Bio-Logic Solutions Corp in Thousand Oaks, CA is seeking a Manager, Clinical Systems (IRT) to lead the implementation and maintenance of interactive response technology for clinical trials. You will collaborate with internal teams and external suppliers to ensure systems meet regulatory standards and company policies.

Responsibilities include overseeing IRT documentation, managing project timelines, and providing training and support to IRT users.

Qualifications

• Experience with IRT (Interactive Response Technologies) or RTSM systems in pharma, biotech, or IRT supplier environments.
• Proven ability to design or maintain IRT systems for clinical trials.
• Experience integrating clinical systems and managing inter-system communications.
• Clear, effective communication and documentation skills.
• Project and stakeholder management within regulated settings.

Responsibilities

• Lead and consult on IRT system design to align with study protocols and regulations.
• Facilitate requirements-gathering meetings with clinical study teams and IRT suppliers.
• Oversee the development of study-specific IRT technical documentation.
• Track and resolve study-related technical issues in partnership with internal teams and vendors.
• Identify and document risks, implementing mitigation plans as needed.
• Manage IRT project timelines and associated deliverables.
• Support cross-functional teams including Clinical Study Management, Supply Chain, and Data Management.
• Negotiate and manage external vendors for IRT technology solutions.
• Ensure all IRT activities follow industry best practices and company policies.
• Provide training and ongoing support for IRT users.

Skills

IRT systems

Pharma/biotech

System integration

Documentation skills

Project management

Vendor management

Regulatory knowledge

Cross-functional

Education

Doctorate

Master's degree

Bachelor's degree

Associate degree

High school diploma

Tools

eCOA

Job description

Contract Length:6 months (Possible Extension)
Compensation: Open Market Rate

Summary of the Role

Join a large biopharma leader as Manager, Clinical Systems (IRT), supporting implementation and maintenance of interactive response technology (IRT) solutions for clinical trials.
Collaborate cross-functionally with internal stakeholders and external technology suppliers to ensure systems meet regulatory, protocol, and company standards.
Provide technical oversight for all IRT system processes and documentation. Contribute to continuous improvement of IRT capabilities and team best practices.

Key Responsibilities

• Lead and consult on IRT system design to align with study protocols and regulations
• Facilitate requirements-gathering meetings with clinical study teams and IRT suppliers
• Oversee the development of study-specific IRT technical documentation
• Track and resolve study-related technical issues in partnership with internal teams and vendors
• Identify and document risks, implementing mitigation plans as needed
• Manage IRT project timelines and associated deliverables
• Support cross-functional teams including Clinical Study Management, Supply Chain, and Data Management
• Negotiate and manage external vendors for IRT technology solutions
• Ensure all IRT activities follow industry best practices and company policies
• Provide training and ongoing support for IRT users

Required Experience & Skills

• Strong experience with IRT (Interactive Response Technologies) or RTSM systems in pharma, biotech, or IRT supplier environments
• Proven ability to design or maintain IRT systems for clinical trials
• Experience integrating clinical systems and managing inter-system communications
• Clear, effective communication and documentation skills
• Project and stakeholder management within regulated settings
• Ability to lead projects on aggressive timelines and support both internal and external IRT users

Preferred Qualifications

• 5+ years focused IRT experience
• Bachelor's degree in life science, computer science, engineering, business, or a related field
• 4+ years working in clinical operations, clinical supply chain, or clinical systems management
• Experience implementing clinical technology solutions, including IRT and eCOA
• Strong working knowledge of Good Clinical Practices and FDA clinical trial regulations
• Demonstrated vendor management, meeting facilitation, and issue resolution skills
• Excellent time management, attention to detail, and organization in a deadline-driven environment
• Ability to work independently and as part of a multidisciplinary team

Day-to-Day Responsibilities

• Serve as champion and consultant for optimal IRT design per protocol
• Facilitate system requirements meetings with clinical and supplier teams
• Design and oversee study-specific technical documents for IRT
• Identify, document, and mitigate issues and risks in collaboration with study teams and technology vendors
• Track technical issues to resolution and closely manage all IRT project timelines and activities

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

This posting is for Contingent Worker, not an FTE