Responsible for collecting data from clinical trials created for pharmaceuticals, biologics, or devices. Ensures data collected is accurate, groups data properly, solves operational problems, and prepares statistical reports.
- Work with complex computerized records systems and maintain security and integrity.
- Collect data from clinical trials.
- Sort information and then ensure it's screened, grouped, summarized, transcribed, coded.
- Consult with other employees to solve operational or data problems.
- Provide clerical duties such as data entry, transcription, coding, and collating searches.
- Prioritize work in line with project management decisions.
- Manage clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines and regulatory agency guidelines.
- Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.
- Generate data retrievals and summaries.
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures.
- Review case report forms for completeness and consistency.
- Implement strategy for data cleaning and the design and programming of clinical databases.
- Review and approve design, data review ground rules and database design according to Standard Operating procedures and protocol.