Job description - Data Manager (DM)
Alternative job titles
Clinical Data Coordinator Clinical Data Associate
Description
The Data Manager is required to manage data in department of Clinical Research studies. He/she is responsible for the creation, updating, maintenance, and validation of clinical study databases, and for the provision of computerised reports of these data. He/she is a key member of the clinical project team and should be able to prioritise work in line with project management decisions. The responsibilities of the Data Manager are to manage clinical trials through review, computerisation, cleaning and auditing of clinical data and data bases in compliance with standard operating procedures, client guidelines and regulatory agency guidelines.
Qualifications
A candidate may require a BS/BA bio-medical or bio-statistical degree, which can vary from a bachelor, master and nursing qualifications. The candidate should have knowledge of ICH-GCP and a strong interest in clinical research, as well as have an affinity with working with databases. Professional use of the English language; both written and verbal.
Competencies
- Ability to work unsupervised taking responsibility for own actions
- Work precisely according to procedures, rules and regulations
- Recognise recurring issues and analyse their causes in order to reach a solution
- Consistency in delivering positive results, following tasks through from start to finish
- Excellent verbal and written communication skills
Tasks
- Review, analyze, and validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines
- Review and approve CRF design, data review ground rules and database design according to Standard Operating procedures and protocol
- Assist in standardizing data management procedures such as documentation for departmental operating procedures
- Develop and maintain documentation and data management guidelines
- Maintain clinical trial data accuracy through review of case report forms for completeness and consistency
- Assist in the development and implementation of strategy for data cleaning and in the design and programming of clinical databases
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines and regulatory agency guidelines
- Generate data retrievals and summaries
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