Clinical Data Manager

If you have worked with several cross-functional teams, across geographic locations to manage clinical data, here is your next challenge.

• 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 and 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 ensures 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.
• Coordination of UAT of eCRF build and validation documents, included 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.

• Leadership
• Communication

• Experience in analysis, design, coding, and testing
• Experience in leading a cross-functional team