Daniela Salvati Email & Phone Number

Taranto, It

- Carry out checks for activities delegated in terms of contractual requirements and timeframes and in compliance with Sponsor/CRO procedures;- Interface with Sponsor representative, Finance and other Company staff to obtain and provide information relevant to the delegated activities and to analyze applicable requirements and procedures;- Act as primary contact for the Sponsor as Project Manager focused on contractual requirements and deadlines and warning/actions to prevent any… Show more - Carry out checks for activities delegated in terms of contractual requirements and timeframes and in compliance with Sponsor/CRO procedures;- Interface with Sponsor representative, Finance and other Company staff to obtain and provide information relevant to the delegated activities and to analyze applicable requirements and procedures;- Act as primary contact for the Sponsor as Project Manager focused on contractual requirements and deadlines and warning/actions to prevent any deviation;- Verify compliance with project monitoring plans, compliance with established deadlines for data management and statistical activities, submission deadlines and regulatory requirements;- Follow-up on any study issue detected and escalate as appropriate;- Establish and maintain SOPs related to Project Control and CTA acitivites;- Prepare and manage study newsletters and specific communications on project tracking and status;- Act to prevent study criticalities, to have a clear flow of activities and to facilitate communication among the concerned parties;- Organize periodic meetings with the study team to share and coordinate project activities;- Provide exports, reports and periodic status updates to the concerned parties;- Carry out the tracking and verification of Sponsor-specific report revision activities according to CRO and Sponsor procedures and Key Performance Indicators and Matrix;- Manage Sponsor specific checks providing report and export;- Sponsor systems management (CTMS): provide operational support to the monitoring team;- Manage specific training sessions on systems and relevant functionalities;- Test new functionalities and/or systems and provide feedback to the Sponsor;- Coordinate the activities delegated and manage resource allocation;- Contribute to hiring and onboarding of new associates and act as a mentor for junior staff;- Responsible for the CTA team;- Responsible for the internal CTM system. Show less

- Carry out checks for activities delegated in terms of contractual requirements and timeframes and in compliance with Sponsor/CRO procedures;- Interface with Sponsor representative, Administration and other Company staff to obtain and provide information relevant to the delegated activities, and to analyze applicable requirements and procedures;- Act to prevent criticalities, to have a clear flow of activities and to facilitate communication among the concerned parties;- Provide… Show more - Carry out checks for activities delegated in terms of contractual requirements and timeframes and in compliance with Sponsor/CRO procedures;- Interface with Sponsor representative, Administration and other Company staff to obtain and provide information relevant to the delegated activities, and to analyze applicable requirements and procedures;- Act to prevent criticalities, to have a clear flow of activities and to facilitate communication among the concerned parties;- Provide exports, reports and periodic status updates to the concerned parties (e.g. enrolment curve, patient status, etc.);- Carry out the tracking and verification of Sponsor-specific report revision activities (printing of documentation, collection of any missing signature, preparation of Transmittal Sheets, update of the tracking tables and update company system);- Establish and maintain SOPs related to Project Control acitivites;- Coordinate the activities delegated and manage resource allocation;- Mentor for junior staff. Show less

- Carry out checks for activities delegated in terms of contractual requirements and timeframes and in compliance with Sponsor/OPIS procedures, as applicable;- Act to prevent criticalities, to have a clear flow of activities and to facilitate communication among the concerned parties;- Provide exports, reports and periodic status updates to the concerned parties (e.g. enrolment curve, patient status, etc.);- Verify that project monitoring plans are complied with for the activities… Show more - Carry out checks for activities delegated in terms of contractual requirements and timeframes and in compliance with Sponsor/OPIS procedures, as applicable;- Act to prevent criticalities, to have a clear flow of activities and to facilitate communication among the concerned parties;- Provide exports, reports and periodic status updates to the concerned parties (e.g. enrolment curve, patient status, etc.);- Verify that project monitoring plans are complied with for the activities of competence (i.e. visits and phone contacts performed within the set timelines and number of visits/contacts consistent with contract provisions, production of relevant reports);- Verify that timelines established for data management and statistical activities are complied with, if applicable;- Manage Sponsor specific checks (e.g. grant management), upon request;- Follow-up on any issue detected and escalate as appropriate. Show less

- Assistance to Project Managers and CRAs: project control for different Sponsors;- Managing monitoring reports, updating key dates, visit status, patient status and study team list;- Checking trial master file;- Assisting project managers in handovers;- Monitoring clinical studies.