Job Description

If you have worked with several cross-functional teams, across geographic locations to manage clinical data, here is your next challenge. Responsibilities & Duties Review documentation and requirements for new projects and anticipate impact to Data Management (DM) standards/processes. Collaborate with client team for all requirement gathering of CRFs, edit checks, subject calendars, user management, reporting requirements etc. Collaborate with internal project team (both onshore-offshore) as needed to stay abreast of changes that could affect data collection, cleaning, change requests and/or transfers. Develop Data Management Plan (DMP), maintain DMP throughout lifecycle of study project and ensure DMP is followed according to study design and requirements. Review Protocols, and develop Case Report Forms and study reports. Develop trial database, including eCRF design, user requirements, edit rules/checks, query logic and data validations. Coordinate UAT of eCRF build and validation documents, including but not limited to: edit check document, issue logs, UAT summary report. Manage eSource/EDC users and other Clinical databases, including but not limited to, compiling master user lists and activating/deactivating user accounts. Perform user training both web-based and in-person at client locations, and create user guides. Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding. Qualifications & Skills Technical Skills: Experience in analysis, design, coding, and testing. Human Skills: Leadership Communication Work / Experience Experience in leading a cross-functional team. #J-18808-Ljbffr CliniOps Inc.

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