Toniann Dattilo

Experience

1. Senior Trial Manager

   Johnson & Johnson

   Oct 2021 — Present · SC, US

   This position is responsible for the local management of a clinical trial in a country. Oversight of assigned protocol(s) at the country level from start‐up through to database lock and closeout activities. Ensure regional/global clinical operations deliverables progress according to the agreed upon timelines and milestones as leader of the Local SMT. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities.Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of pre‐trial assessment visits and appropriate follow‐up of pre‐trial visit report and country feasibility report. Collaborates with central study team for final selection of sites to participate in trial.Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. Set-up country budgets and monitor actuals vs forecast for Out-of-Pocket Expenses, and review assigned vendor invoices/spend.Create and update study-specific documents such as Operational Management Plan, Informed Consent Forms, provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.

Education

• Colorado Technical University

  Bachelor of Science (BS), Healthcare Management

  2014 — 2016

• Colorado Technical University

  Associate of Science (AS), Health Administration Services

  2012 — 2014

• Middlesex College

  Pre-Nursing Studies

  1999 — 2004

• Colonia High School

  Diploma, General

  1988 — 1992

Skills

• Administrative Assistance
• Totality
• Clinical Trials
• Outlook
• Administrative Assistants
• Healthcare
• Greats
• Time Management
• Quality Assurance
• Worksense
• Human Resources
• Pharmadoc
• Standard Operating Procedure (Sop)
• Pharmaceutical Industry
• Sop
• Clinical Research
• Adobe Professional
• Medical Administrative Assistant Skills & Expertise
• Microsoft Office
• Clinical Trial Management System (Ctms)
• Ariba
• CTO
• Etmf
• Gxrs
• Beacon
• Flexplace
• Microsoft Office Suite
• Data Management
• Rtt
• Management
• Eicd
• Clinical Data Management
• Visio
• Microsoft Excel
• Microsoft Word
• Software Documentation
• Ctsrs
• Sharepoint
• Ctms
• Travel Arrangements