Brittany Harvey
Senior Clinical Project Manager
Riverview,FL
Summary
Experienced clinical research professional skilled in coordinating data collection, site operations, and compliance documentation for various clinical trials. Demonstrates exceptional organizational skills and meticulous attention to detail, ensuring thorough planning and effective problem-solving. Possesses extensive knowledge of study protocols, standard operating procedures, and general trial oversight in the field of rare neurological diseases, with over 10 years of experience. Recognized for excellent problem-solving abilities and a detail-oriented nature.
Overview
13
13
years of professional experience
6
6
years of post-secondary education
4
4
Certifications
Work History
Senior Clinical Project Manager
UCB
Cambridge, MA
04.2024 - Current
- Leads cross-functional teams to successfully complete complex clinical trials within budget and deadline constraints.
- Manages multiple vendor relationships and negotiate contracts, ensuring timely delivery of high-quality services while maintaining cost control.
- Enhances patient recruitment and retention strategies, leading to increased enrollment numbers and reduced dropout rates.
- Oversaw site selection and initiates partnerships with qualified investigators, leading to optimized resource utilization and accelerated study start-up times.
- Leads efforts to optimize study site performance by implementing targeted monitoring strategies and providing ongoing support to site staff.
- Serves as a subject matter expert on an internal UCB budgeting and project timing system while supporting fellow colleagues
Clinical Project Manager
UCB
Cambridge, MA
04.2020 - 04.2024
- Led multiple multi-functional, Clinical Study Teams / Joint Clinical Study teams, tailoring communication interfaces to ensure effective co-ordination and communication within and across UCB internal and CRO teams.
- Ensured that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensured that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by CRO.
- Supervised study conduct by regularly reviewing CRO performance through review of KPIs, metrics and deliverables, with focus on critical activities that might delay projects, jeopardize quality, and/or impact on budget.
- Collaborated with members of Clinical Study Teams / Joint Clinical Study teams to develop clinical trial protocols and protocol amendments and study documents by providing input and/or approval as defined in SOPs and, if applicable, Strategic Partnership (SP) documents. Ensure that these documents are appropriately updated, e.g. in case new safety information or other change in scope.
Associate Clinical Trial Manager
Ra Pharmaceuticals Inc.
Cambridge, M
12.2019 - 04.2020
- Assisted Clinical Study Leads with successful execution of clinical studies from study planning to closeout in order to deliver projects on time, within budget, and in compliance to all applicable regulations.
- Assisted in managing study conduct, ensure operating procedures and company policies are followed and trials meet all applicable regulations and guidelines required. Assist with oversight of CRO and other vendors, oversight of contracts, timelines and budgets, for studies done in and outside US.
- Accountable for preparation and finalization of key clinical documents, which include the clinical protocol, informed consent, case report form, and other essential study documents.
- Ensured deliverables are carried out according to the study plan. Ensured enrollment commitments meet projected enrollment across regions at clinical study level, monitor patient recruitment at global level, and ensure timely and accurate documentation and communication of study progress and issue escalation.
- Exhibited proficiency and act as Subject Operations Expert in clinical trials involving complex design issues. Will provide solutions and guidance as needed.
- Interfaced and collaborated with investigators, IRBs/ECs, contractors/vendors and company personnel as required.
Senior Clinical Research Associate
University of South Florida
Cambridge, MA
05.2019 - 01.2020
- Provided industry consultation on training for rare neuromuscular disease endpoint assessments and protocol implementation at site level
- Managed a team of Research Support Specialists in providing superior clinical trial services to patients according to industry standards and identify and resolve conflicts affecting employee performance
- Reviewed accumulating data and communicate with study coordinators regarding data quality and data completeness
- Developed communications and information for Chairman's and division meetings
- Conducted research team meetings to inform staff of updates, issues, or concerns relating to research and patient safety
- Oversaw medical or health recruiting and screening protocols, collecting data for research studies
- Identified areas for process improvement and meet with all staff to update on progress of initiatives, facilitated divisional communication for comprehensive patient care
- Developed annual budget projections and track fiscal accruals, assessments for fiscal processes (invoicing, contracting), facilitate patient and staff travel documentation
- Developed SOP documents: review medical protocol and prepare draft of document; coordinate with protocol Principal Investigator preparation of final document for research staff training
- Oversaw and assisted in protocol development; obtained and maintained regulatory compliance approval for all active research
- Assisted faculty with drafting manuscripts, protocols, and research proposals for publication and other items that may be disseminated
Clinical Research Associate
University Of South Florida
Cambridge, MA
03.2016 - 04.2019
- Monitored unit budget to ensure financial objectives were met
- Assisted in budget negotiations for new clinical trials and recommends changes in procedures in order to best facilitate clinical trial participation for research subjects
- Worked with principal investigator and sponsors to facilitate daily trial activities and ensure compliance with research protocols
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
- Recruited and trained research assistants who gathered data for clinical trials
- Monitored compliance of study procedures with Federal, state and university regulations
- Collaborated with social workers and professional agencies to provide services related to health conditions
- Drafted program reports for publication and/or public dissemination
- Provided education to clients and clients' families regarding clinical protocols
Research Support Specialist
University of South Florida
Cambridge, MA
07.2011 - 06.2016
- Coordinated several clinical research trials in Department of Neurology's neuromuscular division, including submission and maintenance of regulatory documentation
- Assisted principal investigator with rare neuromuscular research trials, including regulatory documentation, generation of source documents, maintenance of study data, enrollment of patients, and performing basic neuromuscular testing for research purposes
- Recorded data and maintained source documentation following good documentation practices with high degree of accuracy and precision
- Wrote and edited data collection forms and questionnaires
- Collected, prepared, tested and shipped a wide range of biological samples
- Evaluated potential subject participants to assess suitability for planned studies
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies
Education
Graduate Certificate - Epidemiology
University of South Florida
Tampa, FL 08.2012 - 06.2014
Bachelor of Arts - Psychology
University of South Florida Honors College Psychology
Tampa, FL 08.2005 - 05.2009
Skills
Experience in clinical rating for rare neuromuscular disease study endpoints and assessments
Experience in building industry and clinical site collaboration for quality improvement
Proficient in use of electronic data capture systems, including iMedidata RAVE, Oracle, DataLabs, Medrio, PharmaEngine, RDC, and InForm
Coordinating clinical research site operations
Certification
ACRP Certified Clinical Research Coordinator
Timeline
Senior Clinical Project Manager
UCB
04.2024 - Current
Clinical Project Manager
UCB
04.2020 - 04.2024
Associate Clinical Trial Manager
Ra Pharmaceuticals Inc.
12.2019 - 04.2020
Senior Clinical Research Associate
University of South Florida
05.2019 - 01.2020
Clinical Research Associate
University Of South Florida
03.2016 - 04.2019
Graduate Certificate - Epidemiology
University of South Florida
08.2012 - 06.2014
Research Support Specialist
University of South Florida
07.2011 - 06.2016
Bachelor of Arts - Psychology
University of South Florida Honors College Psychology
08.2005 - 05.2009
ACRP Certified Clinical Research Coordinator
ACRP Certified Project Management
CITI Certified in Good Clinical Practice
USF CRA-Advanced Designation
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