gabriela szmyd

Planning, coordination and execution of the microbiological project supporting the pharmaceutical products clarity assessment.

Ensuring the delivery and compliance of shared services across drug projects by timely registration of the clinical studies on ClinicalTrials.gov according to the FDA requirements and internal, company policies (what included the coordination of the delivery process, obtaining required approvals and the revision of the submission’s content). Ensuring the delivery and compliance of shared services across drug projects by the preparation and timely submission of the appropriate results summary (Technical Results Summary, CSR Synopsis or both) to ClinicalTrials.gov according to the FDA requirements and internal, company policies (what included the coordination of the delivery process, obtaining required approvals and the revision of the submission’s content). Ensuring the appropriate location of the data on the study/ project level by its receipt and loading to relevant data repositories. Ensuring the quality of the received data on the study/ project level by performing the data comparison against the data standards, interpreting the results and coordination the improvement process.

Leading global project with the objective of maintaining continuous company transparency with regards to led clinical trials and their results. Global monitoring of compliance with FDA and EMA requirements regarding clinical trials registration and results posting on ClinicalTrials.gov and EudraCT respectively. Subject matter expert leading the team of 12 specialists in delivery of legal and administrative formalities connected with the clinical trials registration and publishing their results. Coordination of the publishing process on ClinicalTrials.gov and EudraCT websites. Providing the guidance and expertise for the company units located globally. Establishing and modification of internal procedures, in accordance to the changing regulations. Implementing systems and tools enabling realization. Conducting training for the employees on trial transparency procedures and systems, in direct form during visiting the company’s units as well as via teleconference. Additionally preparing e-learning courses.

Review of the data entered by investigational site to ensure its completeness. Running data integrity checks and review of the reports to identify data inconsistencies or discrepancies from data handling guidelines. Query management using PhaseForward InForm software system. Coordination of project execution on the level of Data Management Centre. Accountability for Quality of Data per Data Review Plan. Sponsor data entry. Study data preparation for Interim analysis and Database locks.

Planning and conduction of the project leading to the identification of Candida species isolated from Tunisian and Portuguese patients using the various methods of molecular biology. Results published: Candida species isolated from human infections from Tunisian and Portuguese patients: Molecular identification and in vitro antifungal susceptibility assessment. Microbes In Applied Research: pp. 500-504 Read More: http://www.worldscientific.com/doi/abs/10.1142/9789814405041_0101