Supports the Data Management team by managing personnel in the design, testing, and implementation of clinical data collection studies. Focuses on oversight of quality data deliverables and projects with Contract Research Organizations.
Requirements
- Participates in the collaboration and coordination of the design and implementation of clinical protocols and data collection systems.
- Assists in the development of data quality plans.
- Ensures data management timelines for assigned projects are met.
- Reviews and resolves data discrepancies for standardized data validation systems and procedures.
- Oversees production of quality data deliverables for assigned protocols to support regulatory submissions, publications and due diligence activities.
- Participates in the review of clinical and regulatory documents, as needed, to assure data integrity and quality.
- Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
- Supports compliance with industry quality standards, guidelines and procedures.
- Assists with the selection, development and evaluation of personnel to ensure the efficient operation of the function.
- Participates in providing suitable input into corporate and department budget process and management