Clinical Data Manager

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.

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