Key skills
CommunicationTime Management
About this role
Role Overview
- Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to Clinical Study Report audits, Protocol audits and Electronic Database Capture (EDC) audits).
- Interact with internal and external clients to discuss QA observations and study-related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
- Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
- Detect quality issues and the need for CAPAs and evaluate deviations
- Assist with the preparation for and hosting of client audits and/or regulatory inspections.
- Participate in the preparation, conduct and follow-up for System Audits and Vendor Audits
Requirements
- Bachelor’s degree in science, IT, business, or similar
- 2-5 years of quality/laboratory/clinical experience
- Excellent oral and written communication skills
- Ability to organize and manage multiple priorities
- Excellent time management skills
- Attention to detail, tactful, and diplomatic
- Proficiency in using electronic data and computerized systems.
- Ability to travel, as needed
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements