Sr. Clinical Trial Manager

• Apr 2021 - Present

Clinical Lead

• Jul 2019 - Present

Managing the clinical operations team to meet the contractual requirements in accordance with the Scope of Work, SOPs, ICH-GCP and Regulatory requirements. Leading, mentoring and training the clinical operations team. Ensure the quality and scientific integrity of the clinical trial using a Risk-Based Monitoring model. Risk identification and management to ensure timely and on-budget project delivery. Present clinical deliverables to the Sponsor. Responsible for site selection and subject recruitment.Study budget management pertaining to the clinical operations team, including EAC forecasting.Participate in and support RFP process (review RFP documents, pricing, attend bid defence meetings). Show less

Associate Clinical Lead

• Oct 2018 - Jun 2019

same as above

Associate Clinical Lead

• Nov 2016 - Oct 2018

Partially covered responsibilities of the Data Team Lead in my first project, besides leading the Clinical Operations team.Created and successfully executed a Data Cleaning Plan. Specified the data checks and the content of data listings required for reviewing the targeted data points. Reviewed the data listings and reconciled the data in order to clean the study database. Identified deviations from the protocol based on the data listings and reconciled them vs. the PD log to assure all PDs were reported.Achievement: The programmed data checks run by the Sponsor after the database lock did not find any discrepancies or deficiencies in the database, nor unreported protocol deviations. Show less

Senior Clinical Research Associate

• Jun 2016 - Oct 2016

Acted as SWAT CRA, being responsible for performing site selection visits.

Assoc. Clinical Research Specialist

• Jul 2012 - May 2016

Main responsibilities included cleaning the clinical study database of large Phase 3 clinical trials.Reviewed Clinical Data listings (SAS listings) based on Comprehensive Data Review checks to identify and resolve discrepancies between the eCRF, vendor databases and protocol deviation log.Prepared eCRF completion guidelines. Created ad-hoc Oracle EDC/Inform reports.Created Excel macros to shorten the review process and to improve the quality of data review.Key member of a study team successfully executing an accelerated project execution plan for a program consisting of 3 projects. Served as a protocol expert for the Clinical team.Acted as regional Clinical Project Manager for an unblinded clinical study team. Prepared training materials and trained CRAs. Organized and led regular CRA team meetings. Reviewed site monitoring visit reports. Prepared study guidelines. Show less

Senior Clinical Research Associate

• Oct 2008 - Jun 2012

Main contact point for investigational sites. Performed all types of site visits from selection to close-out.Mentored junior CRAs.Between 2010 and 2016, acted as a clinical data reviewer cleaning the study database in 9 large Phase 3 clinical trials. The data review work included determination of data checks, review of eCRF and vendor data listings, Tables&Listings review, SAE Log and Protocol Deviation Log review.

Clinical Research Associate

• Apr 2006 - Sep 2008

Main contact point for study sites, performing all types of site visits from selection to closeout, evaluated patients' eligibility, ensured data quality, adherence to the protocol and agreed SOPs.Created, distributed and maintained all relevant study documentation.Mentored trainee CRAs.Prepared Regulatory/Ethics Committee submission packages.

Clinical Research Assistant

• Oct 2005 - Mar 2006

Maintained study master files.Supported the CRA team with site management.Conducted site feasibilities.

Research Scientist

• 1994 - 2003

Performed research work in biophysics: (1) photodynamic diagnosis on tumour bearing mice using endogenous porphyrins; (2) photodynamic inactivation of Escherichia coli bacteria using 5-aminolevulinic acid induced endogenous porphyrins; (3) fluorescence imaging of green leaves. Performed research work in biophysics: (1) photodynamic diagnosis on tumour bearing mice using endogenous porphyrins; (2) photodynamic inactivation of Escherichia coli bacteria using 5-aminolevulinic acid induced endogenous porphyrins; (3) fluorescence imaging of green leaves.