Associate Director, IRT Systems

Job Title: Associate Director, IRT Systems

Job Number: 35306

Location: , 

Job Description

An exciting opportunity is available for an Associate Director, IRT Systems to join the Biometrics team. Reporting to the VP of Biometrics, this role requires expertise in IRT-related integrations and a forward-thinking approach to clinical development operations. The ideal candidate will have strong attention to detail, a collaborative mindset, and the ability to lead and manage multiple projects simultaneously.

Responsibilities

• Serve as the IRT system’s Subject Matter Expert for clinical studies.
• Collaborate cross-functionally to gather requirements and design the IRT system.
• Oversee IRT vendor management, implementation, and integration with EDC and reporting systems.
• Manage user acceptance testing, maintenance, and documentation in eTMF.
• Provide technical support to Clinical Operations, Biostatistics, and Data Management.
• Lead or contribute to process updates, cross-functional initiatives, and SOPs.
• Support inspection readiness activities.
• May act as the business owner for related internal applications.
• Perform additional duties as assigned.

Required Skills

• 5-8 years of clinical supply systems experience in the pharmaceutical or biotech industry
• Bachelor’s degree in a science-based field (advanced degree preferred)
• Proven problem-solving skills and experience with clinical system integrations (IRT, EDC, etc.)
• IRT Subject Matter Expertise
• Experience with vendor management and relationship building
• Knowledge of ICH, GAMP, FDA, IRB/IEC, and clinical research protocols
• Ability to work independently with initiative
• Strong written and oral communication skills
• Proficient in MS Office (Outlook, Word, Excel, PowerPoint, SharePoint)

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