Clinical Data Management
Job Summary
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.
Primary Responsibilities
- 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.
