St. Jude is looking for someone who can take our Clinical Research Systems to the next level. The Director of Clinical Research Systems will get to work with EDC systems, eTMF platforms, randomization tools, and EMR systems. The Director of Clinical Research Systems works under the direction of the CMIO and is responsible for overseeing clinical research management systems and related applications for St. Jude Children's Research Hospital. They will develop policies, procedures and strategic plans for the development and growth of clinical trials and clinical research technology infrastructure. Ensuring adherence to standard operating procedures, good clinical practice and FDA regulations. Serves as a knowledgeable resource about the clinical trial process and procedures at SJCRH and provides education for staff and investigators. Develops collaborative relationships with investigators and other operational colleagues in all functional groups and research domains to build strong cross-functional collaboration.
Bachelor's degree in Computer Science, Information Technology, or a related field required.
Master's degree preferred.
Ten (10) years of progressive experience in the support and implementation of systems to include five (5) years' experience in managing clinical trials applications in a cooperative group or pharmaceutical company, either in an academic or contract research organization (CRO) setting is required.
Management experience is required.
Strong EDC experience is preferred.
Experience with randomization tools is preferred.
Experience in working with researchers and clinicians preferred.
Knowledge of complying with FDA CFR 21 Part II is preferred.
Science or information technology experience preferred.
Knowledge of site and trial management systems is preferred.
Experience with IRB/Committee management platforms.
Experience with electronic medical record systems.
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