Oversee the execution of post-market clinical research to ensure ongoing evaluation of product safety and effectiveness in alignment with regulatory and internal standards. This position plays a key role in maintaining study integrity through careful planning, documentation, and cross-functional coordination.
What You'll Do
- Develop and update study-related materials and training content
- Deliver training sessions to clinical site personnel and internal staff
- Support site initiation, including preparation of essential study documentation
- Track study progress and maintain accurate status records
- Contribute to reports, regulatory filings, scientific publications, and presentations
- Assist in developing study budgets and project timelines
- Monitor for potential quality issues and implement corrective actions
- Organize meetings, calls, and training events as needed
- Review and support data collection and analysis efforts
- Manage resolution of site-level issues and ensure timely follow-up
- Supervise delegated tasks performed by supporting team members, ensuring adherence to protocols and regulations
- Apply standard operating procedures and study management practices to guide daily activities
- Participate in process improvements and ongoing professional development
Requirements
- Bachelor’s degree required
- Minimum of four years of clinical research experience; a Master’s degree may count toward one year of experience
Preferred Qualifications
- Familiarity with Good Clinical Practice (GCP) and regulatory standards for clinical studies
- Strong understanding of medical terminology
