Clinical Trial Manager

• Oct 2021 - Present

Clinical Trial Manager

• Jul 2019 - Dec 2019

Clinical Trial Manager

• Dec 2018 - Jun 2019

Senior Clinical Data Manager

• 2012 - 2018

• Lead all aspects of a global Clinical Data Management outsourced activities: vendor selection, financial negotiation, budget management and oversight, defining milestones and deliverables, set priorities and ensuring that clinical data quality and timelines are met within budget and in accordance with regulatory requirements.• Oversee service providers to perform core data management functions: eCRF, quality checks definition, data cleaning and database locking procedures.• Establish inter- and intradepartmental processes to improve the efficiency and quality of data processing.• Initiate efforts for improving current processes for better efficiency and faster turn-around.• Support the department development of SOPs, procedural documentation and process improvement. Show less

Clinical Quality Control Associate

• 2009 - 2012

• Design eCRF (including edit checks, list of values) and eCRF guidelines, performance of eCRF UAT.• Create core study documents such as: Clinical Quality Plan, SAE Reconciliation Plan. • Train CRAs and study team on EDC and clinical data study requirements.• Ensure data quality, consistency and accuracy according to the protocol and ICH GCP guidelines via periodical data review reports and queries management, SAE reconciliation.• Monitor sites data quality status and performance.• Review and prepare clinical data for lock, archiving of study documentation. Show less

Nurse, cardiology department

• 1999 - 2009

• Shift Supervisor Level Nurse (cardiac conditions such as ACS, CHF, MI, atrial or ventricular arrhythmias, post catheterization/post ablation etc.). EGC reading expertize.

Clinical study coordinator, cardiology department

• 2007 - 2008

• Initiate study set up, maintenance and lock: staff training, preparing subject source data documentation and laboratory kits, participation in subject's enrollment, data entry, data query resolution, study lock and preparing subject's source data for archiving.

Clinical research nurse, cardiology department

• 2006 - 2006

• Monitor subjects enrolled into clinical trials: providing study information, collection/monitoring/reporting of subject anamnesis, vital signs and ECG, blood tests and AEs.