Company: Confidential
Job Title: Associate Director, IRT Systems
Job Number: 84016
Location: , US
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) #LI-DNI
Application Deadline: 2024-09-30
To apply for this job please visit jobrxiv.org.