Parexel FSP is hiring for multiple Clinical Data Manager positions in Mexico, Argentina, and/or Brazil.

Job Purpose

The Clinical Data Manager will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase 1-4 studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance

Key Accountabilities

Be able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
Be able to support several clinical studies with minimal guidance
Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
Be able to perform a thoroughly detailed review of eCRF data requirements.
Interact with CRAs, programmers,



study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
Develop data edit check specifications and run data listings as required
Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
Develop the Data Management Plan for a clinical study.
Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries
Perform reconciliation of header data from external data sources against the clinical database
Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
Assist in database upgrades/migr

📌 Clinical Data Manager (México)
🏢 Parexel
📍 México