John Blanche Email & Phone Number

Philadelphia, Pa, Us

Durham, North Carolina, Us

Dublin, Ie

Dublin, Ie

Manage project support activities in adherence with ICON SOPs and regulationsProvide a high level of customer service, support and quality systems to clientsManage support analysts assigned to projectsLiaise with clients on project related mattersMonitor system changes as needed Provide mentorship and training to new Project Support Analysts as assignedMonitor assigned project systems while proactively identifying potential issues and addressing them in a timely mannerPresent on behalf of ICON at investigator meetingsParticipate in quality assurance and business development activities

Dublin, Ie

•Evaluate new and updated systems to determine the necessary validation steps to assure compliance of all Cardiac Safety systems with industry standards and regulatory requirements.•Write concise and complete documentation to support the validation of clinical data systems. This includes the collection of vendor supplied documentation, as appropriate.•Interact with in-house development staff in the development of system specifications and documentation.•Execute and/or review results from validation protocols for in-house clinical data systems.•Coordinate with operational management in the identification, oversight, and training of end users in the execution of test scripts.•Evaluate results from assigned test programs to ensure accurate and complete documentation and results.•Maintain comprehensive tracking of all test deviations and associated corrective action.•Assist in the audit of external vendors providing technologies or services related to clinical trials•Evaluate clinical systems for compliance with eResearchTechnology standard operating procedures, internal development standards, and regulatory authorities.•Perform ongoing quality reviews of clinical data systems.•Assist in the development of standard operating procedures related to the development, evaluation, implementation, and testing of clinical data systems.

Dublin, Ie

•Provided project support throughout the SDLC for multiple projects involving IVRS/IWR systems.•Worked with various internal departments to maintain accurate system functionality. •Attended sponsor meetings to gather information for relevant system updates and coordinated with project managers and other relevant internal departments to ensure system updates were completed within agreed timeframes. •Worked with internal departments and sponsors during UAT process to ensure accurate system functionality.•Collaborated with sponsor clinical supply teams to maintain sufficient supplies at both depots and investigational sites. •Managed new investigational product release information. •Performed system updates for patient visit and demography discrepancies.•Updated User Requirement, Functional and Technical documents.•Designed protocol specific investigator manuals.•Created call center guidelines for assisting the call center with supporting investigational site and sponsor queries

Harrisburg, Pennsylvania, Us

Master'S Of Science, Clinical Research

Bs, Psychology

A.A., Psychology