Description
Job Responsibilities:- Data cleaning activities including listing review, external data reconciliation and data review
- Reviewing and finalizing all DM related documents including Data Management Plan, edit check specifications, completion guidelines, and CRF design
- Handling of external data and facilitating data transfers to internal and external stakeholders
- Communicating with external vendors to define required file format and content specifications for electronic files
- Overseeing database quality control activities
- Working with the other functional groups within the project team (e.g. Biostatistics, Statistical Programming, Clinical Investigations, Clinical Operations, Research and Development)
- Participating in the development and maintenance of SOPs and process guides related to data management activities
Requirements:
- A BA or BS degree with a minimum of 3 years of directly-related clinical data management experience; 5 years of oncology experience preferred
- Skilled in the use of EDC systems (Rave preferred) and reporting tools
- Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines
- Detailed understanding of project planning and management methods
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment
- Strong SAS skills is not necessary, but would be nice to have
To find out more about Real please visit www.realstaffing.com