Experience

Korio, Inc.

• United States
• Software Development
• 1 - 100 Employee

• Principal Project Manager

  • Nov 2022 - Present

  As subject matter expert, work closely with our customers and Korio team members to define, setup and manage IRT/randomization and trial supply management (RTSM) systems associated with individual clinical trials.Provide continuous feedback to Korio’s roadmap regarding our platform capability and services to perfect our delivery process. Primary point of contact for both the customer and Korio team. Document and manage information flow from various project stakeholders through the Korio platform to enable the setup and management of all phases of customer project implementation.Identify and mitigate risks to project timelines and deliverables to proactively manage outcomes.Collaborate with Korio team members to resolve challenges- early detection and proactive issue resolution.



Worldwide Clinical Trials

• United States
• Research Services
• 700 & Above Employee

• Sr Clinical Systems Project Manager

  • Apr 2022 - Oct 2022

  Manage delivery of quality systems thru coordination and collaboration with key stakeholders in the areas: project scope, budget, resourcing, deliverables and timelines to include vendor deliverables as applicable.As subject matter expert, provide first-line and second-line support, as applicable, to on-going studies for investigation and resolution of issues and/or incidents to include quality checks of manual database edits.Provide stakeholders impact and risk assessment of scope changes, potential course of action(s) and deliverable timelines.



endpoint Clinical

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Lead Project Manager

  • Oct 2015 - Mar 2022

  Primary point of contact for clients, keeping them apprised of all project developments while maintaining high level of client satisfaction which resulted in significant increase of client specific projects.Developed and maintained project schedules, identified and tracked milestones and managed cross-functional dependencies.Subject matter expert in transforming client clinical study protocol and study team needs into system functional requirements, technical specifications, system integration specifications and data transfer specifications.Provided mentoring, training, direction and guidance to 6 - 12 Project Managers with various levels of experience, knowledge and skills.Managed issue escalation through resolution, participated in root cause analysis and triage of non-urgent issues for resolution priority.



Merge Healthcare

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• IxR Senior Project Manager

  • Feb 2013 - Oct 2015

  • Management and direction of the project team including timelines, budget and client deliverables.• Manage client interactions and expectations.• Manage all project documentation and reporting to include the development of specifications.• Contribute to product and Quality Management System document development.• Identify risks and issues that may affect project deliverables and implement mitigation strategies to ensure minimum impact to the project. • Management and direction of the project team including timelines, budget and client deliverables.• Manage client interactions and expectations.• Manage all project documentation and reporting to include the development of specifications.• Contribute to product and Quality Management System document development.• Identify risks and issues that may affect project deliverables and implement mitigation strategies to ensure minimum impact to the project.



INC Research

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, IVR/IWR Systems

  • May 2004 - Jun 2012

  • Identify and resolve issues due to poor system design, inadequate functional specification and/or requirements identification or system user training for IVR/IWR legacy platform systems.• Develop standards for system requirements specifications, database structure, common or base components for stored procedures, confirmation reports and summary reports to streamline system development process, validation test case writing and simplify system support after installation into production.• Implement IVR/IWR systems requiring various randomization designs (non-stratified, multiple stratification factors, adaptive minimization algorithm) and study drug. management strategies (controlled substance, threshold based, just in time shipping, predictive algorithm). • Review GCP validation test cases to ensure testing robustness of high risk requirements and all requirements are challenged.



PPD

• United States
• Research Services
• 700 & Above Employee

• Senior System Designer IVR Systems

  • Mar 2001 - May 2004

  • As IVR Project lead, coordinated with clinical trial study team to define IVR system requirements and design system to support the study protocol and needs of the study team.• Managed project budget and timeline.• Reviewed IVR system design and documentation to ensure accordance with Standard Operating Procedures and Working Practice Documents.• Provided second level system support for complex data changes.• Assisted with bid preparation, development of SOPs/WPDs and standardization of common modules.• Supervised and trained mid-level and associate system designers.• Maintained training and working knowledge of FDA, GxP and ICH requirements.