<p>Position Summary:</p> <p>Provide technical oversight to ensure that IRT solutions are implemented to meet the needs of the study protocol, industry regulations, and best practices. Ensures that the IRT system functions effectively as a crucial component of the clinical trial process, supporting data integrity, compliance, and efficient trial execution. This role involves developing study-specific plans, and overseeing various aspects of the IRT system to ensure it supports the trial's needs and adheres to regulatory guidelines.</p> <p>Principal Duties and Responsibilities include the following:</p> <ul> <li>Manage system changes, updates, and releases, ensuring minimal disruption to ongoing studies. </li><li>Provide expertise and guidance to internal and external stakeholders on IRT-related matters. </li><li>Develop, review and implement study-specific IRT plans, considering the unique needs of each trial. </li><li>Oversee the IRT system's functionality, ensuring it aligns with study protocols and regulatory requirements. </li><li>Identify areas for improvement in IRT processes and implementing solutions. </li><li>Review User Requirements Specification (URS) for accuracy and translate key components to the cross-functional team. </li><li>Review and provide input into UAT test scripts, identifying gaps as applicable </li><li>Participate in the UAT process. </li><li>May manage relationships with IRT vendors, including communication, monitoring performance, and ensuring timely delivery of services. </li><li>Ensure the IRT system complies with Good Clinical Practice (GCP) guidelines and other relevant regulations. </li><li>Ensure IRT complies with needs of supply chain management </li><li>Ongoing IRT consultation, as needed. </li></ul> <p>Qualification Requirements:</p> <ul> <li>10+ years IRT development experience. </li><li>A combination of strong analytical, communication, and project management skills, as well as experience in clinical trials. </li><li>A strong understanding of clinical trial protocols, GCP, GMP, FDA regulations, supply chain management, and relevant industry standards is essential. </li><li>Track record experience with audits/inspections (at least 1). </li><li>Experience with vendor management, meeting facilitation, and presentation skills may also be beneficial. </li><li>Experience with multiple IRT vendors, including Suvoda and Veeva, a plus. </li></ul>