Clinical Data Manager

The Role :

The Clinical Data Manager (CDM) is responsible for clinical data management operations and activities such data review (Query management, data listings review etc.) including external lab vendor and SAE reconciliations. CDM is also responsible for EDC testing and data cleaning.

The CDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; understand the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.

ESSENTIAL FUNCTIONS

• Support Internal Clinical Data Management Initiatives
• Complete assigned Data Management Operations / Activities
• Review CRF / eCRF data for completeness, accuracy, and consistency via system edits and manual data checks (data review listings)
• Contribute to Project Success by conducting duties per LDM / Study lead request.
• Freeze and / or lock eCRFs (as appropriate) within the Electronic Data Capture System (Medidata rave, Veeva EDC etc.)
• Perform external vendor reconciliations.
• Perform SAE reconciliation.
• Code data per selected coding dictionaries if applicable.
• Participate in User Acceptance Testing (UAT) under supervision of the Study Lead.
• Assist with data transfers, loading and integration.
• Complete all required documentation and project requirements
• Manage allocated tasks with minimal oversight, ensuring deliverables meet quality standards and customer expectations.

Ideal Profile :

QUALIFICATIONS FOR ESSENTIAL FUNCTIONS

EDUCATION AND EXPERIENCE REQUIRED

WORK REQUIREMENTS

TRAINING

What's on Offer?