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Clinical Data Manager - FSP

Parexel
- Remote (Colombia)
- 1w ago

Parexel FSP is hiring for multiple Clinical Data Manager positions in Colombia, 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 activememberofamulti-disciplinaryteamtoplanand executetheDataManagementtasksrequiredfor 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 Advers

📌 Clinical Data Manager (Colombia)
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