Perform site selection, initiation, monitoring and close-out visits in accordance with protocol and GCP. Administer protocol and related study trainings to assigned sites, communicate with sites regularly to manage ongoing project expectations and issues, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion, data query resolution, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans submitting regular visit reports, follow-up letters and other study documentation. Collaborate with study team members.

Perform monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of NIS and Phase III Novartis Pharma clinical trials.

Performed all monitoring activities

Creating study relevant documents (Protocol, IB, ICF), performing and coordinating all aspects of the clinical monitoring process from "start up" to "close out", performing with project-specific administrative activities, communication with investigational sites. My responsibilities include moreover to provide project-specific training for site team, to to assure effective patient identification and recruitment plan in place, to assure timely reporting of AE/SAE and protocol violations, to update study and patient status information. Took part in 2 clinical trials in the area of urology and in several bioequivalence trials.

Investigators/sites selection, study documents preparation, monitoring activity, preparation of Ethics Committee submissions, notifications to regulatory authorities, sites initiation, coordinating and close out activities, study feasibility, reporting of significant issues noted to appropriate personnel. Took part in clinical trials in the area of gastroenterology, oncology, therapy, pulmonology and cardiology as well as in countless bioequivalence trials.