Client-focused Clinical Project Manager Resume
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Resume:
PROJECT MANAGEMENT SUMMARY
+ years of focused Cardiovascular Service experience across various therapeutic areas including: adult and pediatric hypertension, type diabetes, multiple sclerosis, Parkinson’s disease, and advanced solid tumors. Effectively managed the start up, maintenance, and close out activities of multiple Phase I-IV, multicenter, US and global clinical trials on time, within scope, and compliant with study protocols, FDA guidances, GCPs, and SOPs. Demonstrated ability to lead teams and coordinate cross-functional activities to streamline documents, instruction, and systems to increase efficiency and obtain milestones.
· Technology Management
· Logistics Management
· Training & Mentoring
· Development of SOPs
· Organizational Skills
· Client Relationship Management
· Written & Verbal Communications
· Budgeting & Cost Control
· Problem Analysis/Resolution
PROFESSIONAL EXPERIENCE
BioClinica (Formerly CoreLab Partners, Inc. and Medifacts International, Inc.) ? August to November
Clinical Project Manager, Cardiovascular services
· Project Management Specifics: Developed and maintained clinical trial documents including, but not limited to: Operations Charters, Communication Plans, Project Plans, System Setup Guidelines, and Study Specific SOPs. Conducted training and ensured proper resource allocation for study teams. Fostered communications between internal team members and sponsors delivering study updates and information on a routine basis. Provided logistical and/or customs requirements for US and global studies. Presented and discussed service offerings during bid-defense and investigator meetings.
· Data Management: Contributed to Data Transfer Plans and cardiac assessment CRF sections. Identified and analyzed data quality issues to initiate immediate corrective action plans and proactively contributed to overall risk assessment plans. Monitored and cleaned data according to specified data management guidelines.
· Reporting: Created study-specific reports and Excel spreadsheets to deliver study metrics and updates to the sponsors and investigative sites resulting in attainment of all milestones.
· Budgeting & Cost Control: Maintained study budgets to produce invoices and spend tracking. Evaluated scope changes to address costing modifications throughout the lifetime of the studies.
Key Accomplishments:
· Efficiently managed coinciding US and global Phase I Thorough QT clinical trials.
· Managed the implementation, validation and testing, and training of several cardiac software enhancements
Medifacts International, Inc. ? August to August
Project Coordinator
· Coordination: Facilitated communications between internal team members and investigative sites pertaining to study start up activity, such as equipment training; equipment and data management issue resolution and/or escalation; and study completion activity, such as coordination of equipment returns and document archiving.
· Data Management: Monitored and resolved technical issues at the investigative sites and maintained this information for sponsors and internal team members.
· Training: Provided clinical investigative sites and sponsors with telephone and in person training on an assortment of blood pressure and ECG devices.
Key Accomplishment:
· Promoted to Project Manager.
Algorithme Pharma (Formerly Bioanalytical Systems, Inc.), ? January to August
Participant Services and Recruitment Representative
· Recruitment: Identified and recruited applicants for Phase I clinical trials.
· Coordination: Collaborated with study teams and participants to schedule visit and testing appointments.
· Data Management: Maintained, recorded, and updated databases with the latest information from test results and observations.
Key Accomplishment:
· Successfully met each recruitment deadline for coinciding trials.
Geisinger Health Systems/One Source Staffing Solutions ? August to January
IT Trainer
· Project Management: Coordinated planning activities, training, testing, and all documentation support for system upgrades and new installations.
· Organization: Developed new project maps and revised existing ones.
· Training: Developed training plans, materials, and documentation.
Key Accomplishment:
· Assisted in the development and execution of EPIC computer program for three participating hospital emergency rooms.
EDUCATION
· Bachelors of Science, Biology, Pennsylvania State University, University Park, PA –
· GCP Training, BioClinica – annual training from -
