Description
Key Features--Review data and generate queries according to the data validation specification (DVS)
- Maintain documentation relating to clinical data management including maintaining the data management portion of the Trial Master File (TMF) (and auditing existing TMFs to assure completeness)
- Data Validation Specification (DVS) writing
- Data Management Plan (DMP) writing
- Interface with site personnel, monitors and clinical operations staff to provide support related to data management (including EDC system issue resolution)
- Interface with EDC vendor regarding issues/bugs/new releases etc.
- Correspond with and oversee data management vendors
- Coordinate dictionary coding and assist with coding as needed
- Provides early strategic input into protocol design focused on data management issues
- Participate in recurring data management meetings and maintain issues within ticketing system
- Assist with the development of timelines and budgets
- Assist in streamlining clinical data management procedures to create effective practices
- Set up studies (and modify existing studies) in EDC system and design Case Report Forms (including testing and documentation of testing)
- Writing and testing of XML edit checks
- Train monitors and site personnel on EDC system
- Correspond with monitors regarding data issues
- Import/export data and report generation from EDC system
- Program tables and listings for recurring meetings, CSRs and ad hoc scientific meetings
- Contribute to Statistical Analysis Plan writing
- Coordinate with pharmacovigilance to review and generate queries related to serious adverse events
- Perform tasks according to company standard operating procedures (SOPs)
- Assist in the development of Data Management SOPs
Skills and Qualifications-
-Bachelor's degree or equivalent experience
-Minimum of five years of direct clinical data management experience in the biotechnology or pharmaceutical industry
-Working knowledge of Good Clinical Practices and ICH guidelines related to CDM
-Exceptional organizational skills, highly adaptive in the face of changing priorities and practices
-Effective written communication skills
To find out more about Real please visit www.realstaffing.com