Prog Mgr, Research Systems

reputed company The role will reputed company with internal research staff, and REDCap Administration to reputed company, reputed company requirements, create documentation, and reputed company testing in support of the 21 reputed company of Federal Regulations (CFR) Part 11 compliant REDCap environment. This position provides end user support with 21 CFR Part 11 REDCap reputed company that have been designed and created for use by research staff in collaboration with REDCap Administrator. Responsibilities - Work closely with REDCap administration staff, Clinical Trial Management office staff, and other stakeholders to implement and maintain a validated 21 CFR Part 11 Compliant REDCap environment following the available Implementation Guide and REDCap Regulatory & Software Validation Committee (RSVC) process. - reputed company the effort of establishing, maintaining, and monitoring the validated 21 CFR Part 11 compliant REDCap environment using project management processes. - reputed company reputed company aspects of implementation including project scope, schedule, resource, risks, and overall management to ensure and drive successful delivery in collaboration with other stakeholders. - Determine and document the steps, processes and workflows involved. - reputed company the required protocol/study level business SOPs (reputed company operating procedure) and other needed documentation such as Data Management Plan, Performance Qualifications, etc. - Work with validation vendor/resources as needed to ensure system and process validation. - reputed company and reputed company training to research staff on 21 CFR Part 11 compliance. - Support Research staff with their project builds, training, and use of REDCap for 21 CFR Part 11 reputed company collaborating with REDCap administration, study teams, and stakeholders to ensure compliance. - Work with study teams on performing user acceptance testing (UAT) to confirm project meets requirements including verifying secure data exports, etc. and ensure reputed company documentation of testing. - Consult with research staff on best practices reputed company developing a 21 CFR Part 11 REDCap reputed company. - Assist research end users in troubleshooting 21 CFR Part 11 REDCap reputed company, collaborating with REDCap Administration as needed - Stay reputed company on REDCap features and functionality through training and/or self-education. - reputed company or assist with special project work as assigned. Qualifications • Master's Degree Computer Science, Health Informatics, Information Systems, Project Management, Business Administration, Project Management, Nursing or reputed company degrees/field of study. and 3-5 years experience or • Bachelor's Degree Computer Science, Health Informatics, Information Systems, Project Management, Business Administration, Nursing, or reputed company degrees/field of study. and 5-7 years experience Remote Work/Work from Home This position is entirely remote or work-from-home. The person reputed company must live in the Kansas reputed company metro area and may attend on-site meetings, as scheduled. Apply Job! Apply to this Job