Daniela Gozzi Email & Phone Number

Wien, Österreich

Vienna, Austria

Vienna

- Documentation and Maintenance of the EDV log-file - Setting-up of computer equipment for new staff/ setting-up the appropriate accounts- Updating the homepage and intranet- Assisting with Hardware/Software problems

Vienna

- Monitoring the progress of a clinical trial and ensure that it is performed, recorded and reported in accordance with the Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements- Conducting site initiation visits, monitoring visits and close out visits- Preparing monitoring reports including all appropriate follow-up activities- Verifying case report forms and source documentation- Performing IP accountability and… Show more - Monitoring the progress of a clinical trial and ensure that it is performed, recorded and reported in accordance with the Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements- Conducting site initiation visits, monitoring visits and close out visits- Preparing monitoring reports including all appropriate follow-up activities- Verifying case report forms and source documentation- Performing IP accountability and reconciliation- Ensuring appropriate safety reporting Show less

Vienna

- Generation of SAS programs within a PDLC, file compare, data cleaning, QC audit of database, SAE reconciliation - Running Installation Qualification (IQ) and Operational Qualification (OQ) tools (SAS, R)- Validation/testing according to the test plans

Vienna

- Ensuring that clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and local regulations- Responsible for study start-up activities, including creating, preparing and distributing Study File Binders, collating, preparing, maintaining essential documents, and updating study systems- Providing input into feasibility and identifying clinical investigators- Tracking and maintaining adequate study-related… Show more - Ensuring that clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and local regulations- Responsible for study start-up activities, including creating, preparing and distributing Study File Binders, collating, preparing, maintaining essential documents, and updating study systems- Providing input into feasibility and identifying clinical investigators- Tracking and maintaining adequate study-related supplies in the office and facilitating their distribution to sites, including Site Initiation presentations/materials- Maintaining site study supplies incl. Case Report Forms (CRF) and Patient Reported Outcomes (PRO).- Coordinating translation of and/or translating documents- Prepareing informed consent form- Coordinating and performing study submissions to the Ethics Committee- Maintenance of Trial Master File- Assisting in preparing sites for audits/inspections, reviewing audit/inspection reports and contributing to resolving findings Show less

Vienna

- Entry and quality check of eCRF data- Administrative support of the local team

Master Of Science (M.Sc.), Verhaltensbiologie, Neurobiologie Und Kognition

Master thesis: "Sex Differences in Gesturing and Gesticulation" Institute for Anthropology, University of Vienna, Austria

Bachelor Of Science (B.Sc.), Biomedizin Und Biotechnologie

Bachelor thesis: "Influence of abiotic and biotic factors on the parasite load of wild house mice" Department of Evolutionary Biology.

Veterinary Medicine

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