Tony Kuo

Oversee clinical trials, manage teams, ensure compliance, drive timelines and contribute to strategic planning, timely submission, strong team performance and positive regulatory outcomes.

Bridges scientific expertise, strategic planning, and occupational execution to ensure the successful development of innovative therapies for unmet medical needs.

In my role as a Clinical Team Manager II at ICON Strategic Solutions, I provided project oversight and leadership for clinical deliverables, managed vendors, and liaised with relevant staff to ensure data availability. I identified and mitigated data-related risks, developing contingency plans to minimize impact on clinical activities.

Provides Project Oversight & Leadership for Clinical Deliverables. Vendor management and budget/invoice review. Liaises with relevant staff to provide data, as required. Works with the relevant staff to identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks. Interfaces with relevant team members and vendors as required ensuring clinical monitoring outcomes are achieved.

Manages Site Start Up tasks, site feasibility and provides support during recruitment activity. Contributes to process improvement and training. Ensures adherence to study timeline and budget. Manages CROs and Vendors for site issues and supplies. Mentors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues. Monitor key performance indicators (KPIs) and metrics to track trial progress and communication site/study progress and issues to trial central team. Oversee Clinical Monitoring activities and site visits to ensure data integrity and regulatory compliance. Leads and participates in special initiatives as assigned.

INC Research, INC. (CRO) - Sr. CRA (Nov 2015 to Aug 2016). Premier Research (CRO) – Sr. CRA (Nov 2014 to Nov 2015); CRA II (Jul 2013 to Nov 2014) Monitors (remote, onsite, or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations. IP Monitors Conducts Observation Visits and mentors Jr. CRAs. Maintains project tracking system of subjects and site information as applicable. Manages query resolution process with sites and data management. Plans day to day activities for monitoring of a clinical study and sets priorities per site. Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum (Rescue Study) Monitors with knowledge of quality/scope and budget parameters. Works with the Clinical Manager (CM) to enhance and proactively manage site visits and trial issues during the monitoring phase. Manages query resolution process with sites and data management. Maintains project tracking system of subjects and site information as applicable.

Sr. CRA I (Jun - Jul 2013), CRA II (Apr 2011 – May 2013), CRA I (Mar 2009 - Mar 2011) Sr. Global Clinical Trials Assistant (Mar 2008 – Mar 2009) -Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. -Assist with periodic review of study files for accuracy and completeness. -Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. -Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. -Function as a central contact for the clinical team for designated project communications, correspondence, and associated documentation. -May perform assigned administrative tasks to support team members with clinical trial execution. -Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or Line Manager (LM). -Conduct monitoring and co-monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice and applicable regulatory requirements.

Implement SOP – purchasing/sourcing/warehouse management. Supervise Engineer team, Buyer, Sourcing Logistic Coordinator – RFQ, First Article, BOM Manage multiple accounts/projects simultaneously. Host meeting / Presentation, Manage, and track twelve projects simultaneously.

Researched and assisted in the development of novel drug therapies (testosterone and pain management) Participated in drug manufacturing and QC/QA protocols.

Collaborate closely with Military Physician Assistants Oversee 60+ soldiers. Assess patient’s medical history and perform vital sign checks.