|제목||Country Lead Monitors (CLM)|
|모집기간||2018-05-09 ~ 2018-05-23||상태||선별중|
|모집부서||Site Management / Pharmaceuticals|
Country Lead Monitors (CLM) is accountable and responsible for: To ensure consistency, quality and efficiency across the Country CRA Study Team, a CLM is assigned for every participating country and is responsible for and oversees the CRAs and study progress at the country level from study feasibility to study archive. Requires significant country cross functional collaboration throughout the study conduct.
- Leading cross-functional Site Selection Team to identify and determine interest and suitability of investigator’s for participation in the assigned study.
- Developing Core Country Study Documents to initiate the study and ensures all study sites are initiated according to planned study timelines.
- Managing country budget and payments in appropriate tools.
- Ensuring all country CRAs are trained sufficiently for the trial. Identifies training gaps if additional training is required at country level works with the Study Lead Monitor to develop further training plans.
- Overseeing Country Study Oversight Plan to ensure quality and compliance which may include co-monitoring visits and coordinating Data Verification Initiatives.
- Proactively identifying potential or actual country related issues. Responsible for Country Level Corrective Action / Preventive Action Plans (CAPAs) to ensure timely and sufficient resolution of issues.
- Creating Country Monthly report and proactively notifying SLM and SM Country Head of any potential issues with proposed solutions to ensure country participation remains consistent with country commitments.
- For outsourced studies: the CLM is the primary contact with the country CRO team and will support the CRO with regulatory and ethics submissions. In addition, the CLM may conduct co-monitoring visits with the CRO as detailed in the Study Oversight Plan.
- Bachelor’s Degree (or equivalent) with 6 – 7 years of relevant healthcare experience including 4 years of monitoring & site management experience.
- In-depth knowledge of the drug development process including monitoring and site management, local and international regulations, ICH – GCP, drug safety requirements, data management processes and investigator grant parameters to be responsible for site management and monitoring of applicable Phase I and all Phase II-IV complex and global clinical trials.
- Awareness and understanding of cultural differences as well as regional operational differences and budget management.
- Effective written and verbal English communication skills
- Strong oral presentation, interpersonal, decision-making and issue resolution skills, effective planning and organization skills, attention to detail and excellent follow through