- Rockville
- 4–6 years
Lead the implementation of Risk-based Quality Management across studies, develop dashboards and reports, and oversee data integrity and monitoring.
Responsibilities
- Single point of accountability to embed the application of RbQM aligned with the study planning, study protocol, SOP, ICH GCP, and regulatory requirements for assigned studies.
- Ensure monitoring mitigations to study and data risks are fit for purpose and included in the appropriate operational plan.
- Work with Operations team to define oversight plan.
- Work with Data Management to ensure fit for purpose automated and manual cleaning checks in place.
- Work with Clinical Trial Manager to define CRA strategy.
Requirements
- Bachelor's Degree Science related field, or equivalent work experience