Associate Director Clinical Operations

Tundra Technical Solutions; Cambridge (MA); On-site; USD 140,000 - 175,000; Full time

Job summary

A leading company is seeking an experienced IRT Project Manager to join their Clinical Business Operations team. In this role, you will lead the setup and management of IRT systems across clinical studies, ensuring compliance and supply chain readiness. The ideal candidate will have extensive experience in clinical development, project management, and a strong understanding of GCP and GMP. Join a team dedicated to transforming hope into reality for patients.

Qualifications

• 8+ years of experience in clinical development with IRT expertise.
• Proven success in project management and vendor oversight.

Responsibilities

• Lead setup and management of IRT systems across clinical studies.
• Ensure compliance with study protocols and GxP regulations.
• Coordinate user acceptance testing with study teams.

Skills

Project Management

Communication

Collaboration

Job description

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Associate Director, Clinical Business Operations – IRT Systems

Are you ready to help transform hope into reality?

We’re seeking an experienced IRT Project Manager to join our Clinical Business Operations team. In this role, you’ll lead the setup, testing, and ongoing management of Interactive Response Technology (IRT) systems across clinical studies (Phases I–IV), ensuring safety, compliance, and supply chain readiness for investigational products.

What You'll Do:

• Serve as the IRT subject matter expert and lead cross-functional setup and maintenance of IRT systems.
• Ensure IRT systems align with study protocols and GxP regulations.
• Act as a key stakeholder in vendor selection and ongoing IRT supplier oversight.
• Support clinical study protocol development—particularly around randomization, blinding, and product attributes.
• Coordinate user acceptance testing (UAT), script review, and execution with study teams.
• Implement clinical supply strategies within IRT in collaboration with Investigational Supply Operations (ISO).
• Provide IMP drug handling training to internal teams and external investigational sites.
• Support audits, issue resolution, and performance monitoring of IRT vendors.
• Contribute to building IRT standards and efficiencies across clinical studies.
• Ensure compliance with SOPs, GCP, ICH guidelines, and ethical/legal standards.

What You Bring:

• 8+ years of experience in clinical development, with deep IRT and drug development expertise.
• Proven success in project management, vendor oversight, and cross-functional collaboration.
• In-depth knowledge of GCP and GMP.
• Strong communication and presentation skills.
• Passion for excellence and alignment with core values like urgency, thoughtfulness, and patient-first mindset.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Information Technology

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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