PRECIOUS ANOSHIRI

• Provided oversight of study deliverables in 3 Late stage Oncology studies.
• Managed 3 close out studies as General GSM, Lab GSM, ePRO GSM, and Imagining GSM.
• Reviewed and update of ICFs and master clinical study agreement.
• Collaborated with external vendors, reviewing and approving study specific documents.
• Contributed to budgets management (invoice review and reconciliations).
• Liaised with Clinical Supply Chain Project Managers for tracking of IP and other study materials.
• Collaborated with Local Study Teams and vendors for sample repatriation and destruction.
• Collaborated with Local Study teams and vendors for epro/ecoa device management and archiving processes.
• Facilitated interactions with internal functions such as Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including CROs and other external service providers ensuring efficient study delivery to time, costs and quality objectives.
• Met KPIs at above 86%

• Led priority KPI, extended Scope Oncology studies as Point of Contact (POC). Overseeing study state, ensuring that KPIs are met, ensuring that timelines and deliverables are met, identifying potential risks, mitigating such risks, delegating team responsibilities, participating and representing Global Trial Safety Review Center (TRISARC) in stakeholder meetings, reviewed team performance, tracking study metrics using EDC system query Management tools, and provided study team leadership.
• Provided backup to Scientist Associate Directors (SADs) and supported global medical teams and GST.
• Contributed to meeting agendas in Core and Extended Scopes.
• Mentored and trained onboarding Scientists and Senior Scientists, and constantly provided support to my teammates.
• Reviewed Large amount of trial safety data in extended and standard scopes using medical review tools and EDC, checking for logical and medical consistency, and clarifying discrepancies via queries, making Important Medical Escalations (IMEs) to Global Medical Team.
• Contributed in staff retraining.
• Reviewed Global Physicians Report (GPR) on monthly bases for medical consistency, while supporting DM for data coherence as part of extended scope.
• Reviewed Logic and performed User Acceptance Testing (UAT) for my programmed listings as part of my extended scope.
• Set up, reviewed, and published Medical Oversight Plan (MOP) for one of my studies.
• Contributed in Clinical Study Report narratives preparations for Independent Data Monitoring Committee (IDMC).
• Created and presented monthly Study Safety Period Review (SSPR) to Core and Extended Teams archiving them in eTMF.
• Set up and led departmental knowledge sharing, process standardizations, and mentoring initiative.

• Mentored and trained onboarding specialists on department and company SOPs.
• Reviewed large data identifying discrepancies and reconciling when applicable.
• Analyzed claims, assessed eligibility, and sent them for processing
• Followed up with clients when required per SOP.
• Collaborated with internal and external stakeholders both locally and globally.
• Worked flexible hours in a hybrid-working environment.

• Created and reviewed Case Report Files.
• Collected anamnesis to help establish a diagnosis.
• Examined patients physically and instrumentally.
• Established preliminary diagnosis and final diagnosis under supervision.
• Assisted and performed surgical procedures under supervision.
• Presented cases and case histories at medical conferences and rounds.
• Wrote case summaries for conference and internal publications.
• Mentored and taught 3 - 5 year medical students as an assistant.