Clinical Systems Manager (IRT)
Location: Remote (U.S. – standard business hours, Monday–Friday; West Coast candidate preferred)
Employment Type: Full-Time, Contingent Worker (Contract, W2)
Compensation: Open Market Rate

 

Summary of the Role
Join a large biotech pharmaceutical leader as a Manager, Clinical Systems (IRT). You will provide technical oversight for Interactive Response Technology (IRT)/Randomization and Trial Supply Management (RTSM) solutions supporting clinical trials. This role ensures IRT systems align with study protocols, industry regulations, and company policies, while collaborating with stakeholders and external vendors to deliver high-quality systems on time.

Key Responsibilities

• IRT Design & Oversight

  • Guide IRT system design to align with protocol requirements and operational needs

  • Lead system requirements-gathering meetings with study teams and IRT suppliers

  • Oversee development of study-specific IRT technical documentation

• Project & Vendor Management

  • Manage IRT systems through the full software development lifecycle (SDLC)

  • Document and track issues/risks, implementing mitigation plans in collaboration with study teams and vendors

  • Negotiate with external vendors and manage stakeholder relationships

  • Closely monitor project-related timelines and deliverables

• Regulatory & Compliance

  • Ensure all IRT activities comply with GCP, FDA, and other applicable regulations

  • Maintain IRT-related documentation in a regulated environment

• Stakeholder Support

  • Provide specialized user support for internal and external IRT stakeholders

  • Act as a subject matter expert for IRT systems and integrations with other systems

Required Experience & Skills

• Strong expertise in IRT/RTSM systems, with experience designing or maintaining IRT solutions for clinical trials

• Experience managing IRT systems through the SDLC

• Familiarity with how IRT systems integrate with other systems

• Project and stakeholder management in a regulated environment

• Pharma, biotech, or IRT supplier background required

• Strong communication skills and the ability to support users in a “white glove” role

Preferred Qualifications

• 5+ years focused IRT experience

• Bachelor’s degree in life sciences, computer science, engineering, business, or related discipline

• 4+ years in clinical operations, supply chain, or clinical systems management

• Experience implementing clinical systems (IRT, eCOA)

• Knowledge of GCP and FDA regulations for clinical trials

• Vendor management experience

• Strong facilitation, time management, and organizational skills

• Ability to manage multiple projects against tight timelines

Top 3 Must Have Skills

1. Technical expertise in IRT systems

2. Project and stakeholder management experience

3. Comfort managing documentation in a regulated environment

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