Etai Zafrany

As an Area Site Management Lead, I'm responsible and accountable for directing CRAs in a matrix environment and for driving the successful execution of clinical site management study deliverables for assigned studies within a a geographical area. Working in the sub-division of the Oncology Therapeutic Area from early phases to phase 3 studies.

• Manage and oversee day-to-day monitoring activities on assigned study/is to ensure Clinical Site Management deliverables are met by tracking and maintaining project metrics and status of deliverables
• Proactively communicate and escalate issues, risks and mitigation plans to Area/Country Leadership
• Primary point of contact for CRAs for study and site questions
• Accountable for creating and driving recruitment plans for their assigned study(is) within their geographic Area. Accountable for delivering site selection per targets at country/area level.
• Represent Area as part of a coordinated study leadership team directed by the global lead in the delivery of on-time and on-target quality CSM deliverables
• Review completed Site Feasibility Questionnaires, ensures adherence to monitoring plans (SEV, STV, on-site/off-site, COV)
• Conduct trending, assessment of risk, mitigation plans, root cause analysis for issues and emerging issues.
• Partner with study leadership and local affiliate management on issue identification and addressing issues. Develop monitoring tools for trial, drive implementation and ensure consistency across area. Provide monitoring plan training and ongoing non-clinical CRA training
• Conduct CRA teleconferences to deliver training and information as required. Attend study team meetings as applicable and disseminate information, as necessary.
• Liaise with study-start-up to ensure timely site start-up
• Contribute to ongoing process improvement initiatives within their geographic area.

• Managed multiple clinical trial projects simultaneously, maintaining strict deadlines and budget requirements.
• Reviewed incoming data for consistency and accuracy, ensuring high-quality results in cancer research studies.
• Developed close working relationships with site coordinators for seamless communication between all parties involved in the study.
• Continuously updated internal databases with patient data collected from participating sites, ensuring accurate and up-to-date information.

Lead study coordinator for early development studies - Neurology and Ophthalmology units