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Click here or scroll down to respond to this candidateCandidate's Name Philadelphia PA 19108, EMAIL AVAILABLE, PHONE NUMBER AVAILABLEProfessional Summary:Accomplished Biomedical Research Consultant with over 15 years of experience in reference diagnostics, clinical research and hospital laboratory sectors.Proven expertise in healthcare leadership, risk assessment, vendor management, regulatory compliance, and standard operating procedures (SOPs) training and communication initiatives.Ability to lead cross-functional teams in clinical outreach, product development, strategic laboratory management and continuous improvement focused on key performance indicators.Effective customer service and personnel training, contributing to successful sales execution, laboratory oversight, technical proficiency and data monitoring.Improved inventory management and product safety testing processes supporting clinical studies, project tracking and documentation, patient safety and managing budgetary initiatives.Skills:Healthcare Leadership/Patient Safety Audit Acumen Risk Assessment/Mitigation/Management Project/Protocol Management Data Analysis/Integrity Process Improvement/Documentation Vendor/Sales Management/Partnership/Collaboration Communication Strategies Change Control Implementation/measurement of Key Performance Indicators/Budgetary components.Education: Doctor of Healthcare Administration (DHA) University of Lynchburg (VUL) Lynchburg, VAMaster of Health Administration (MBA) Eastern University St. David s, PA.Bachelor of Organizational Management (BA) Immaculata University Immaculata, PA.Associate of Laboratory Science (AS) Harcum College Bryn Mawr, PACertificate of Higher Education Teaching Harvard University Bok Center for Teaching and Learning.Professional Experience: Biomedical Research Consultant Apr 2019 Jul 2024Fujirebio Diagnostics, Inc. Risk Assessment of projects, Documentation of vendor management agreements and contract negotiations, regulatory compliance, standardization and training of SOPs, communication, continuous improvement and identification of key performance indicators.Cardiac Medical Services, Inc. Clinical outreach services and product development initiatives of innovative wearable cardiac technology including customer service training and review of data monitoring documentation. Provided feedback to enhance technological advancements.Hassman Research Institute Oversight and training of research laboratory processes and personnel including SIVs, study-specific clinical instructions and monitoring of protocol compliance and review of laboratory specimen results for inclusion/exclusion of clinical trials.Johnson and Johnson: Updated inventory control system and redesigned equipment and supply storage areas as well as supported product safety testing, shipping and interpretation of clinical laboratory results in support of ongoing clinical studies and projects in support of budget initiatives.Wuxi App Tec: Document review and oversight of investigations involved in nonconformances, deviations and CAPAs. Reviewed SOPs for accuracy and clarity of instructive content. Assisted with gathering data and reports and communication of project progress and completion.Quest Diagnostics, Inc Oversight and monitoring to ensure regulatory compliance, patient safety and quality experience initiatives, test requirements, coaching, training, budget and inventory.Sekisui Diagnostics Sales initiatives and implementation of customer product training aids. Provided input and customer feedback into inventory improvement and product development.Salem Medical Centre Supported hospital laboratory management improvement projects. Improved SOPs and training initiatives. Provided leadership to Core Laboratory Personnel.Riddle Memorial Hospital Technical performance of patient specimen testing procedures, adherence to hospital policies and procedures, regulatory compliance, system and equipment proficiency and maintenance in accordance with laboratory quality standard processes.PRA Health Sciences Marlton, NJ Dec 2015 - Apr 2018 Laboratory Operations ConsultantLaboratory Team Lead support/input to study specific execution of contracted Pharmaceutical Clinical Trial Protocols in conjunction with a collaborative interdisciplinary Research Team.Accomplishments: Evaluation/acquisition/implementation of systems to streamline flow through clinical areas to reduce turnaround time through investigation and contract negotiation.Utilized study specific checklists to effectively execute/delegate all laboratory tasks of multiple clinical trials simultaneously to reduce numbers of queries and audit findings.Decreased routine supply shipping expenses through implementation of a replenishment system to alert vendors when inventory was diminishing and needed replacement.Improved regulatory compliance through acquisition and installation of a temperature monitoring system and a maintenance system for equipment calibration.Jennersville Community Hospital Jennersville, PA May 2014 - Nov 2015 Laboratory ManagerAchieved efficient and effective oversight to all aspects of Clinical Laboratory ServicesDepartmental performance improvement through team building processes.Budgetary benchmarks to decrease OT and check key performance indicators.Attended hospital management team meetings with input from the laboratory department.Negotiated with vendors to secure updated equipment and systems.Conducted Performance Evaluations for staff in conjunction with HR guidelines |
