Associate Director, Clinical Operations/Country Manager
About the role
About Precision for Medicine
Precision for Medicine is a Clinical Research Organization. Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
Position Overview
Due to our continued growth we are seeking a Associate Director, Clinical Operations/Country Manager to be based in South Korea.
The Associate Director, Clinical Operations/Country Manager, provides leadership to the Clinical Operations Department (Clinical Trial Management/Clinical Monitoring). This role ensures the delivery of high quality, timely and cost-effective clinical trial operations in compliance with ICH-GCP, Federal regulations, SOPs and other applicable regulations. The Associate Director collaborates with executive management on the ongoing development of the Clinical Operations Department and contributes to the business plan at both the tactical and strategic levels.
Essential Functions
- Contributes to the development and revision of Clinical SOPs and department guidelines to ensure adherence to applicable ethical, regulatory and clinical standards.
- Ensures CRA resources and other Clinical project resources are continuously adequate; interviews and selects CRAs for studies.
- Coordinates the activities of employees and contract Clinical Operations team members; designates site assignments, tracks and reviews monitoring reports and calendars. Assists in the resolution of employee and contract CRA performance issues, including termination of contracts as needed.
- Represents Clinical Operations on company-wide project teams.
- Assists with the Clinical Operations and Project Team Meetings, including development of meeting agendas and minutes.
- Produces periodic reports.
- Provides input regarding Clinical Operations for proposals, budgets and contracts; participates in bid defense meetings.
- May participate in the analysis and development of Clinical Operations and Project Management department budgets.
- Hires and trains Clinical Operations staff.