לא צויין
נקבה
לא צויין
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מלאה
מיידית
תואר שני
עברית
אנגלית
רוסית
רכב פרטי – רישיון ב'
רכב פרטי
Professional Experience
● Syneos Health – Global Clinical Trial Manager /Project Manager Operations and Quality Assurance/Line Manager | 2020–Present
● Served as Clinical Functional Lead, overseeing site management, clinical, and central monitoring activities across assigned studies across different time zones
● Managed feasibility assessments, site selection, initiation, and activation in alignment with sponsor and regulatory requirements across multiple countries, including the EU, LATAM, Japan, and South Korea .
● Provided leadership and support to start up activities and to monitoring teams, including CRA performance oversight, mentoring, and resource allocation
● Provided direction and accountability for the operational teams and their delivery at the regional and site level.
● Oversight of the staff workload, support performance appraisal, career development training, coaching, and mentoring the team
● Involved in hiring, onboarding, and integrating new Clinical Operations employees
● Oversaw enrollment performance and implemented mitigation strategies throughout the projects
● Ensured quality compliance with study protocols, ICH-GCP, and local regulations by reviewing site activities and addressing quality issues.
● Responsible for setting and achieving quality goals and metrics associated with KPI
● Managed clinical trial budgets, performed forecasting, and ensured deliverables were met within timelines and financial targets.
● Monitored data quality and integrity through regular reviews, tracking protocol deviations, and implementing corrective actions across multiple countries
● Involved in hiring, onboarding, and integrating new Clinical Operations employees
● Led the development and maintenance of key study documents, including SOP, Clinical Monitoring Plans (CMP), Study Reference Manuals (SRM), and eTMF plans. Support protocol development, ICF review, operation feasibility, site selection strategy
● Acted as the primary liaison with sponsors, regulatory authorities, and internal stakeholders,
● Responsible for managing key processes such as CAPA , Vendor compliance, risk assessment, training, and Internal /External Audit, Management control, and service needs
● Supported global audits and inspections, ensuring inspection readiness and successful outcomes
● Represent Clinical Operations at the Sponsor and internal audits.
● Conduct regular discussions with direct reports and lead team meetings at the regional and manager team level. Travelled abroad to oversee the site selection, activation, and monitoring activities to ensure regulatory compliance, adherence to ICH-GCP requirements, and study timelines, and resolved operational risks. Development and implementation of quality control
● Maintenance, revision, and establishment of processes on the regional level
● Ensuring smooth operation from Study Startup to Study Close-out stages
● Communication point to investigators, regulatory and ethics authorities, clients, and vendors for various project-related matters
● Work with Director/Senior Director and/or VP Clinical Operations to communicate all critical issues, business growth opportunities, developing key relationships as well as providing input regarding budgeting discussions to drive productivity and quality within the region.
● Lead CRO and vendor selection process (Bid defense, scoring and contract oversight
● Syneos Health – Senior CRA | 2017–2020
● Manages site performance, monitoring visits, and clinical trial execution across all phases.
● Provides technical support and training to junior CRAs and staff.
● Ensures compliance with GCP, SOPs, and regulatory guidelines.
● Oversees site documentation, data integrity, SAE reporting, and query resolution.
● May lead CRA teams and support business development activities.
Syneos Health – Project Manager and Data Manager | 2017–2020
● Project Management in data quality review and Quality assurance.
● Clinical Quality Control and Data Management.
● Data review across multiple systems, creating queries in systems and developing EDC manual , WI instruction
● Syneos Health (Previous INC Research CRO ) – Senior CRA | 2014–2016
● Ensured subject rights, safety, and well-being through proper informed consent processes and regulatory compliance.
● Conducted site selection, monitoring, and close-out visits to ensure protocol adherence and accurate data reporting.
● Oversaw SAE/AE documentation, drug accountability, and proper filing of study documents in compliance with IRB/IEC requirements.
● Quintiles Ltd, Netanya, Israel – Senior CRA and Study Start Up | 2011–2013
● Conducted clinical monitoring and site management.
● Oversaw SAE/AE reporting, site contracts, investigator training, ISF management.
● Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines
● Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
● Contributed to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent
Senior Medical Sales Representative and Product Specialist 2009-2011 in Oncology, Neurology therapeutics & Hematology sales
- Collaborate with internal teams, including medical, marketing, and market access, to deliver seamless customer experiences. - Analyze market trends, strategic marketing , competitor activities, and customer feedback to inform strategies.
- Build and maintain strong relationships with healthcare professionals, hospitals, and oncology centers
- Support to healthcare professionals, ensuring optimal treatment decisions.
- Ensure all activities comply with ethical standards and local regulations.
Therapeutic Expertise
· Oncology and Hematologic Oncology: Breast, Lung (NSCLC), Prostate, Sarcoma.
· Immunology and Inflammatory Diseases
· Neurology: MS, Alzheimer’s.
· Cardiology: Ischemic Heart Disease, CHF.
· Immunology & Infectious Disease: Autoimmune, RSV, Hepatitis B.
· Other: Ophthalmic, Diabetes, Asthma, Cystic fibrosis, Kidney diseases, Psoriasis, Anemia in chronic kidney disease.
Education
M.A., Consultant Development of Organization – Ariel University
B.A., Health Management Organization and Economy– Ariel University
University Study Medicine -Physician associated for 3 years
Profile
Clinical Trial Manager /Project Manager, Operations and Quality Assurance Manager with 14+ years in global CROs (Phases I–IV). I am skilled in site management, monitoring and oversight, risk management, audit & quality management, and regulatory compliance. Experienced in leading cross-functional teams, managing budgets, and delivering complex trials across oncology, ophthalmic, neurology, cardiology, immunology, endocrinology, pediatric, rheumatology and infectious diseases. Strong background in Quality Assurance, Clinical Quality Control, and Data Management. Fluent in English, Hebrew, and Russian.
Skills
Strong time management, leadership, planning, presentation skills, result &detail-oriented approach, problem-solving, and organization skills
