Jordan Pansky
New York,NY
Summary
Data-and tech-oriented Clinical Study Manager with 7+ years in clinical operations and 4+ years leading end-to-end pre-market medical device trials (Feasibility & IDE). Experienced in clinical monitoring and site management delivery, CTMS/EDC oversight (Viedoc design & UAT), TMF inspection readiness, risk-based monitoring, and study financial tracking. Proven ability to lead and mentor CRA teams, manage vendor/CRO relationships, and align cross-functional stakeholders to meet milestones and financial goals.
Overview
1
1
Certification
8
8
years of professional experience
Work History
Clinical Trial Manager
Butterfly Medical Ltd./Inc.
New York City, NY
08.2023 - Current
- Managed Clinical Research Associates (CRAs) and supported study operations for a 20-site U.S. pivotal (pre-market) study from start-up through database lock, overseeing site monitoring, source document verification (SDV) and data flow via EDC dashboards and trackers.
- Oversaw site monitoring visits to protect project schedules and ensure consistent achievement of study timelines, implementing corrective actions to maintain enrollment and follow-up targets.
- Identified, assessed, and mitigated operational risks, preserving site and patient enrollment schedules across all clinical sites.
- Developed clinical study documentation including Standard operating procedures (SOPs), informed consent forms (ICFs), and case report forms (CRFs); prepared and presented KPIs and study status updates to executive leadership.
- Developed clinical study documentation, including standard operating procedures (SOPs), informed consent forms (ICFs), and case report forms (CRFs); presented KPIs and study status updates to executive leadership.
- Provided intra-procedural technical support and physician training for medical device procedures under anesthesia, ensuring protocol adherence and high-quality data capture.
Clinical Trial Manager
Check-Cap LTD.
Israel, Israel
09.2022 - 08.2023
- Managed Clinical Research Associates (CRAs) and supported study operations for a 20-site U.S. pivotal (premarket) study from start-up through database lock, overseeing site monitoring, source document verification (SDV) and data flow via EDC dashboards and trackers.
- Joined and oversaw site monitoring visits to protect project schedules and ensure study timelines (including data lock) were consistently met; implemented corrective actions to preserve enrollment and follow-up targets.
- Identified, assessed, and mitigated operational risks, preserving site and patient enrollment schedules across all clinical sites.
- Directed study start-up, ethics committee (IEC/IRB) submissions, and regulatory documentation for 10 clinical sites in accordance with GCP and applicable regulatory standards; coordinated site activation and monitoring activities.
- Developed clinical study documentation, including standard operating procedures (SOPs), informed consent forms (ICFs), and case report forms (CRFs); prepared and presented key performance indicators (KPIs) and study status updates to executive leadership, ensuring informed decision-making.
- Managed study budgets with study-specific financial tracking, forecasts, site payments, and invoice reconciliation to support project financial goals.
- Tracked investigational device logistics, product reconciliation, and chain-of-custody to ensure protocol adherence and data integrity; supported clinical supplies and shipment readiness.
Clinical Studies Leader
Check-Cap LTD.
Israel, Israel
09.2020 - 09.2022
- Coordinated site identification, feasibility, qualification, initiation, and close-out activities across 10 active clinical sites, enhancing monitoring activities and ensuring TMF completeness.
- Monitored pre-market and multi-site clinical investigations to ensure studies were conducted in strict compliance with ethical standards, ISO 14155, and ICH-GCP; implemented corrective actions when issues were identified with coordination with Quality assurance team (QA).
- Delivered technical application support and product training to operators, ensuring correct implementation, protocol execution, and standardized data collection.
- Assisted site staff with device operation and troubleshooting, promoting consistent data capture and protocol adherence across clinical settings.
Clinical Application Specialist
EndyMed Medical LTD.
<ul>
<li>Delivered technical application support and product training to operators, ensuring accurate implementation, protocol execution, and standardized data collection.</li>
<li>Assisted site staff with device operation and troubleshooting, promoting consistent data capture and adherence to protocols across clinical settings.</li>
</ul>, Israel
01.2019 - 01.2020
- Delivered technical application support and product training to operators, ensuring accurate implementation, protocol execution, and standardized data collection.
- Assisted site staff with device operation and troubleshooting, promoting consistent data capture and adherence to protocols across clinical settings.
Education
Master of Arts (M.A.) - Statistics and Quality Studies
University of Haifa
IsraelIsrael
Bachelor of Arts (B.A.) - Cognitive Science and Psychology
Ben Gurion University
IsraelIsrael
Skills
- Clinical Operations & Strategy
- Site monitoring
- Site activation
- Product reconciliation
- Budget reconciliation
- Investigational product reconciliation and accountability
- Clinical operations
- Clinical data management
- Budget Forecasts and Reconciliation
- Budget Forecasts & Reconciliation
- Vendor oversight
- Regulatory compliance
- ISO 14155, FDA Regulations, ICH-GCP
- EDC system management
Certification
- ICH-GCP R3 Certified
- CRA Certified
Languages
- English, fluent
- Hebrew, native
Timeline
Clinical Trial Manager
Butterfly Medical Ltd./Inc.
08.2023 - Current
Clinical Trial Manager
Check-Cap LTD.
09.2022 - 08.2023
Clinical Studies Leader
Check-Cap LTD.
09.2020 - 09.2022
Clinical Application Specialist
EndyMed Medical LTD.
01.2019 - 01.2020
Master of Arts (M.A.) - Statistics and Quality Studies
University of Haifa
Bachelor of Arts (B.A.) - Cognitive Science and Psychology
Ben Gurion University