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Job Description
- Ensure timely standard and requirements compliant with clinical project deliverables
- Coordinate CRF design as established standards and applicable protocol, build, test and validate clinical database.
- Develop and execute SOPs, departmental guidelines and data standards to guarantee database quality control and data management compliance
- Document, verify, validate and execute regulatory compliant programs to perform CDM activities.
- Engage in study planning to ensure timely commencement of CRF and database design and edit checks.
- Guide teams to methods of capture data e.g. electronic data capture
- Guarantee the user acceptance testing, data transfer requirements and deployments of clinical trial sites are well defined.
- Develop requirements of edit checks to guarantee high data quality and develop reports
Job Requirements
- Advanced knowledge of Data Management process and systems.
- Solid understanding of Clinical Drug development process.
- Excellent written and oral communication skills.
- Proven leadership skills.
- Excellent organizational skills and demonstrated ability to manage projects.
- Effective problem-solving skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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