Thomas Visonà Email & Phone Number

Verona, Veneto, Italia

The Computerized System Validation Administrator carries out the administrative tasks of the CSV Unit ensuring compliance with applicable regulatory requirements and industry standards relating to hardware qualification and software validation and controls.

Verona

Collaborates with the Clinical Research Division Senior Director (CRDIV-SD) in improving efficiency, effectiveness and adoption of internal tools and procedures Monitors and enforces compliance to CROMSOURCE systems, databases and tracking toolsPerforms quality control checks to ensure the compliance to the databases and tracking tools and assists with data query resolutionInteracts with Clinical Research personnel, as directed, to complete assigned tasksTakes part in the periodic project meetings and updates on the compliance to the databases and tracking tools under close supervision of the CRDIV-SDSupports the Clinical Research personnel in solving issues arisen during the fulfilling of the tracking toolsCollaborates with CRDIV-SD in ensuring that the Clinical Research personnel, following appropriate trainings, are knowledgeable of the clinical research tools application Cooperates for preparing the SOPs related to the application of clinical research databases and tracking tools in collaboration with the CRDIV-SD and the Quality System Unit (QSU)Collaborates in complying and enforcing Company procedures.

Verona, Italia

- Acts as a tutor for the Clinical Trial Administrators (CTAs)- Cooperates with HCTAU as speaker in CTA seminars- Cooperates with HCTAU in managing the workload of CTAs organizing periodic meetings - Assess and verifies the planning of all the start up activities for the assigned projects- Supervises CTA activities in terms of Competent Authorities(CAs)/Ethics Committees (ECs) approvals and archiving- Supports CTAs in solving issues arisen during the clinical projects- Assisted the project team with accurately updating and maintaining clinical tracking systems- Responsible for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports according to the scope of work and the SOP’s.- Prepared and requested the necessary local authorities approvals.- Oversaw and managed the agreements with hospitals and investigational centres.- Collaborated with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project).- Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.- Collaborated with the project team in organizing Investigator’s and Monitor’s Meetings- Collaborated in managing the follow-ups of the monitor’s activities.- Managed the telephone monitoring of projects.- Oversaw and managed the payments of sites.- Kept himself professionally of all regulatory and operative aspects relevant to the clinical projects he will be assigned; Following appropriate trainings, in the application process for clinical studies, in force in the country(ies) of work. - Accordingly he could required to provide updates on the applicable regulation for the application process in the country of work, whenever relevant.

Verona, Italia

- Assisted the project team with accurately updating and maintaining clinical tracking systems- Responsible for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports according to the scope of work and the SOP’s.- Prepared and requested the necessary local authorities approvals.- Oversaw and managed the agreements with hospitals and investigational centres.- Collaborated with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project).- Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.- Collaborated with the project team in organizing Investigator’s and Monitor’s Meetings- Collaborated in managing the follow-ups of the monitor’s activities.- Managed the telephone monitoring of projects.- Oversaw and managed the payments of sites.- Kept himself professionally of all regulatory and operative aspects relevant to the clinical projects he will be assigned; Following appropriate trainings, in the application process for clinical studies, in force in the country(ies) of work. - Accordingly he could required to provide updates on the applicable regulation for the application process in the country of work, whenever relevant.

Verona, Italia

- Assisted the project team with accurately updating and maintaining clinical tracking systems- - Responsible for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports according to the scope of work and the SOP’s.- Prepared and requested the necessary local authorities approvals.- Oversaw and managed the agreements with hospitals and investigational centres.- Collaborated with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project).- Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.- Collaborated with the project team in organizing Investigator’s and Monitor’s Meetings- Collaborated in managing the follow-ups of the monitor’s activities.- Managed the telephone monitoring of projects.- Oversaw and managed the payments of sites.

Verona, Italia

- Cooperated with the project team with accurately updating and maintaining clinical tracking systems.- Responsible for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports according to the scope of work and the SOP’s.- Prepared and requested the necessary local authorities approvals.- Oversaw and managed the agreements with hospitals and investigational centres.- Collaborated with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project).- Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.- Collaborated with the project team in organizing Investigator’s and Monitor’s Meetings- Collaborated in managing the follow-ups of the monitor’s activities.- Managed the telephone monitoring of projects.- Oversaw and managed the payments of sites.

Verona, Italia

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Verona, Italia