09 oct
|
Parexel International
|
Ciudad de México
09 oct
Parexel International
Ciudad de México
Parexel is hiring a Senior Clinical Data Manager in Mexico or Argentina.
The Senior Clinical Data Manager will be responsible for performing Data Management activities that support client's commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.
Essential Functions
Be able to lead a large clinical study or a series of related studies with minimal guidance
Represents Data Management on the CTWG for assigned studies
Provide mentoring and training to lower level Data Management staff assigned to his/her studies
Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
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.
Lead the development of data edit check specifications and data listings
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 or lead the development of 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
May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
Perform reconciliation of header data from
📌 Senior Clinical Data Manager (Ciudad de México)
🏢 Parexel International
📍 Ciudad de México