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Click here or scroll down to respond to this candidateCandidate's Name , DR.PH, MSCJacksonville, FL USA PHONE NUMBER AVAILABLE EMAIL AVAILABLESUMMARYAs a seasoned and results-driven research professional, I possess a robust understanding of health program management, clinical research, and strategic planning, coupled with direct patient care expertise. My profound interest lies in the realms of Health Economics & Outcomes Research, Public Health, and related fields. I excel at identifying innovative treatment approaches to effectively serve underserved populations on a global scale. I've collaborated with international, diverse teams of physicians, researchers, and influential thought leaders to execute program objectives. SKILLS Critical Thinking Data Analysis Research Methodology Literature Review Problem-Solving Communication Project Management Teamwork Technical Skills Ethical Research Adaptability Attention to DetailWORK EXPERIENCEAssociate Director 08/2022 to CurrentOctapharma PARAMUS NJ Contribute to strategic planning for optimized clinical development plans. Acquire in-depth knowledge of the therapeutic area and products. Demonstrate a comprehensive understanding of ICH/GCP requirements, principles, industry practices, and standards. Participated in all study activities, including protocol review, development of study materials, clinical trial site selection, contractor/CRO management, and safety reporting. Take responsibility for departmental resource management, budgets, benchmarking, performance reviews, SOPs, and guidelines. Interact regularly with upper management in a global context. Senior Manager Clinical Operations 09/2019 to 06/2022 AnGes USA INC. BETHESDA, MD Led a team of 8 individuals, including Project Managers, Lead CRAs, CRAs, and Clinical Trial Assistants, as well as an Administrative Assistant. Provided oversight to external vendors, including a Contract Research Organization (CRO), to manage all functions during Phase II clinical trials. Conducted site feasibility assessments and participated in site selection processes. Reviewed project budgets, invoices, and timelines in collaboration with the accounting department. Developed presentations for weekly team meetings to ensure cross-functional alignment within internal departments. Project Manager 06/2017 to 09/2019SUPERNUS PHARMACEUTICALS, INC. ROCKVILLE, MD. USA Established and maintained relationships with Key Opinion Leaders (KOLs), investigative sites, and patient education groups. Provided scientific support for company projects, delivering presentations to investigative sites. Served as the Project Manager for a $60 million CNS/ADHD Phase III study. Ensured protocol compliance by monitoring the performance of the CRO (Contract Research Organization). Contributed to the site identification, selection, and initiation processes, including on-site visits to establish direct company contacts, ensure regulatory compliance, and represent Supernus at industry events and advisory board activities. Clinical Research Associate II-Lead 06/2017 to 06/2018 SUPERNUS PHARMACEUTICALS, INC. ROCKVILLE, MD. USA Coordinated and participated in Initiation Visits with Site Monitor and CMO, delivering required training. Maintained responsibility for tracking and reporting study progress to the Clinical Trial Manager. Provided support in monitoring and engaged in co-monitoring activities as needed to ensure accurate and timely data entry. Actively participated in regular calls and meetings with the Clinical Trial Manager, Director of Clinical Operations, and, when necessary, clinical team discussions with the CMO and CEO. Conducted reviews of study documents and SOPs for completeness and clarity, while also leading and managing cross- functional team resources and external service providers for trial execution. Research Collaborator, Predoctoral Fellowship 11/2016 to 11/2017 NATIONAL INSTITUTES OF HEALTH (NICHD) BETHESDA, MD. USA Conducted laboratory work with a focus on developing and characterizing mouse models to gain insights into the pathological processes associated with genetic disorders. Utilized molecular, biochemical, and proteomic techniques for analysis. Conducted retrospective chart reviews as an independent contributor to research projects, poster presentations, publications, and manuscript submissions. Managed all aspects of planning and overseeing Phase II/IIIb clinical trials, including conducting Human Factors Studies for Lifecycle Management Products. Provided clinical trial determinations in accordance with the requirements of the National Institutes of Health (NIH), Food and Drug Administration (FDA), and International Committee of Medical Journal Editors (ICMJE). Oversaw the collection, processing, storage, distribution, and management of various biospecimens. Clinical Trial Manager, Contractor 11/2016 to 07/2017 VTESSE INC. ROCKVILLE, MD. USA Led Program Risk Management, including facilitating mitigation and contingency planning for key program risks. Aligned product development teams with the target product profile, timelines, budget, and senior management's strategic intent. Provided process management and expertise to product development teams, ensuring optimal execution of product development. Assisted in developing and guiding a significant program's strategic direction and execution by fostering cross-functional communication and alignment, achieving Corporate and Program goals, and serving as the partnership/alliance management interface. Played a pivotal role in recommending courses of action for business process improvements and supporting infrastructure, while effectively interacting.Certified Clinical Research Coordinator 03/2010 to 11/2016 MAYO CLINIC JACKSONVILLE, FL. USA. Managed site initiation visits and study start-up procedures, utilizing EDC and IVRS systems for record-keeping, patient tracking, and drug accountability. Conducted and coordinated all activities related to clinical research independently. Developed complex procedures and policies for patient testing in accordance with the study protocol. Created and implemented instructional and educational materials for patients, such as diaries, pamphlets, and instructional videos. Acted as a liaison and resource person for the Principal Investigator, assisting in the interpretation and implementation of research activity guidelines, policies, procedures, and regulations. Healthcare Quality Improvement Fellow 02/2012 to 06/2013 MAYO CLINIC JACKSONVILLE, FL. USA Collaborated with physicians and senior managers to analyze and enhance patient cost definitions, develop strategies to boost patient satisfaction, and increase staff engagement in clinical services using quality improvement tools and motivational approaches. Achieved a 20% enhancement in population health, patient experience, cost of care, and care outcomes through the successful execution of strategic initiatives. Reduced clinic delays by 80% and increased patient volumes by 22% through the development and implementation of a three-part improvement project. Advocated for and achieved a 20% reduction in indirect patient costs within the department, leading to a remarkable 30% increase in patient satisfaction. Strengthened external stakeholder partnerships by providing senior management with insights into projected financial and treatment outcomes resulting from quality improvement efforts. Clinical Data Manager II Office of Clinical Trials 07/2007 to 03/2010 M. D. ANDERSON CANCER CENTER ORLANDO Orlando, FL Evaluated and reported adverse events in accordance with the study protocol. Prepared audit materials for specific studies and agencies/cooperative groups. Reviewed audit findings and recommended corrective and preventive actions when necessary. Regularly updated the department director on study progress and compliance. Contributed to internal monitoring and quality assessment efforts and assisted in training new Data Managers. EDUCATIONMBA: Business Administration 2013Nova Southeastern University JacksonvilleMSc, Health Science: Education & Sports Medicine 2011 Nova Southeastern University JacksonvilleBachelor of Science: Health Care Management 2008Southern Illinois University CarbondaleDoctor Public Health: Epidemiology 2019Capella University MinneapolisCERTIFICATIONS Navy Commendation Medal Clinical Research Training Online Monitoring Clinical Studies NIH Human Subject certification, ACRP, CCRC Good Clinical Practice, Adverse Event Reporting, Basic Hematology/Chemistry, Biopathology, Data Abstraction, Protocol Overview, Regulatory Compliance |
