Valentina Dal Chiele

• Initiate investigator site activities, including collection and submission of regulatory documents and serve as the point of contact for a site’s Ethical Review Board (ERB) and Competent Authority (CA).
• Work with Informed Consent Form updates, collaborating with sites on updates and ensuring appropriate IRB submissions and approvals.
• Collect essential regulatory documents from sites, and ensuring compliance with regulatory and ICH/GCP guidelines and Lilly SOPs.
• Communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract.
• Track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities.
• Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
• Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
• Populate internal systems systems to ensure accuracy of trial/ site performance.
• Understand and comply with procurement, legal and financial requirements and procedures.
• Populate Trial Master Files (Veeva Vault) and perform Annual reviews.
• Utilize the Clinical Trial Management System (CTMS) to ensure subject status, site communications, site contacts, project information and institutional review board submissions are accurately tracked, current, and complete.
• Perform study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study. Works closely with cross-functional study team (CRAs, CMAs, CTMs, PMs, etc.)
• Provide feedback and shared learning for continuous improvement

· Regulatory Lead for multiple Clinical Trial projects with more than 30 protocols.

· Responsible Person for EudraVigilance and EVWEB submissions.

· Quality Control certified to review various safety activities (expedited SUSAR submissions and periodic submissions DSUR) performed by other team members.

· Process Lifecycle Safety (LCS) data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs), project requirements and report to Competent Authorities (RA), Ethical Review Board (ERB), institutional review boards (IRB), and investigators per legislation and within timelines.

· Able to work with strict deadlines ensuring high quality standards.

· Produce status reports and enter monthly project metrics in PSA system.

· Able to Investigate and report Non-compliance Occurrences (NCOs) and Significant Unplanned Deviation Reports (SUDRs).

· Perform Annual File Reviews, and reconciliation lists.

· Use electronic Trial Master File (eTMF), Wingspan, and Trial Interactive to file a variety of safety documents, e.g.

· Alert Letters and Compliance Reports.

· Use of electronic Trial Master File Review Tool to review and close the Action Items.

· Use of Argus Safety Database for data entry, report generation and tracking submission.

• Regulations for the Global Market Access department.
• Provide logistical support to the R&D department.
• Collaborate with MDs performing clinical trials with Actial Farmaceutica products.
• Oversee customer support, complaints, and adverse events.

Laboratory research assistant in the Department of Medical Genetics. ResearchedPolE and PolD genes associated with colorectal carcinoma. Performed DNAextraction, PCR, and gene sequencing (NGS).