Rocky Mount, North Carolina, United States
With over 16 years of experience as a clinical research professional, I'm skilled in addressing clients needs, managing teams cross-functionally, and identifying innovation solutions to challenges.
Provides project leadership and oversight for global and regional projects, pressure testing teams on deliverables and timelines. Develops study management plans, including project and vendor management plans. Provides oversight for the feasibility, planning, and initiation activities on assigned protocols. Oversees the development of trial management systems, providing status reports on issues and escalating queries for third party vendors. Manages study scope, budget, timelines, trial master file, risk assessments, and recruitment strategies on assigned protocols.
Provided project leadership for vendors and global projects. Managed client relationships and expectations on assigned projects. Built relationships with vendors and escalated issues as needed. Oversaw development and support of various clinical software programs. Contributed to change management and revenue recognition on assigned projects.
Established and managed project timelines and risk management activities. Reviewed and managed project expenses, resourcing and initiates change order process. Developed and maintained project execution plans with guidance from project leader. Managed setup and maintenance of trial master file and coordinates file review with project team. Prepared status reports, meeting minutes/actions, and presentation materials for study team and customers.
Principal support contact for internal data modeling tool. Tracked and resolved issues identified by internal customers. Created and maintained training documentation for data modeling tool. Identified, evaluated, and implemented processes for improved use of tool. Routinely organized and conducted training meetings for project teams.
Main point of contact for sponsor and clinical users of IRT systems. Collaborated daily with sponsor and clinical team members to ensure proper function of IRT systems. Coordinated and lead team meetings and occasionally records meeting minutes. Identified potential issues with IRT system and discusses solutions with sponsor and clinical teams. Routinely created training documentation for site, clinical and sponsor personnel.