Remote IRT Project Lead

NCBioImpact; Durham (NC); Remote; USD 110,000 - 125,000; Full time

Job summary

NCBioImpact is seeking an IRT Project Manager to lead study-specific IRT implementation efforts, ensuring timely delivery and quality. You will coordinate cross-functional teams across Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, and vendors.

You will define study timelines, oversee UAT, URS review, and documentation, and manage contracts and budgets. Strong attention to regulatory requirements (GxP, ICH E6) and cloud-based IRT best practices are essential.

Qualifications

• University/college degree in life sciences, health sciences, IT or related field, or equivalent certification.
• 5–6 years of clinical systems project management experience with IRT/eCOA focus.
• Fluent in English, written and spoken.

Responsibilities

• Lead study-specific IRT implementation teams with cross-functional stakeholders.
• Create and manage IRT timelines and deliverables.
• Review vendor specifications and integration documents.
• Facilitate IRT study review meetings and URS/UAT activities.
• Ensure completion of IRT documentation and study closeout deliverables.
• Coordinate data exchange requirements between IRT and other systems.
• Manage contracts, budgets, and change orders for IRT studies.
• Provide guidance on best practices and process improvements.

Skills

Vendor management

Stakeholder management

UAT

Software validation

Project scheduling

Education

Life sciences / IT degree

Tools

eCOA platforms

Regulatory TMF systems

Job description

NCBioImpact is seeking an IRT Project Manager to lead study-specific IRT implementation efforts, ensuring timely delivery and quality. You will coordinate cross-functional teams across Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, and vendors.

You will define study timelines, oversee UAT, URS review, and documentation, and manage contracts and budgets. Strong attention to regulatory requirements (GxP, ICH E6) and cloud-based IRT best practices are essential.