Experience

Emergent BioSolutions

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Data Manager

  • 2020 - Present

  Lead the design of CRFs, CRF completion guidelines, and data handling conventions in close collaboration with the clinical study team, develops logic and/or reviews edit check specifications; programs and validates and/or validates edit checks to facilitate cleaning of clinical data. Responsible for database design, programming and validation, and maintenance for clinical study databases with a focus on accurate data collection and compliance with data standards and SOPs. Coordinate and perform successful conduct of user acceptance testing with participation of Clinical and Biostat team. Assist in the creation, review, and oversight of document such as Data Management Plans, eCRF completion guidelines, and source documents for completeness and consistency. Manage of external data specifications (such as laboratory or EKG data specifications) in consultation with Clinical Operations and Statistical Programming. Lead review of EDC data for completeness and correctness, querying of sites for problems, issues, or trends and escalation within Clinical Development as necessary. Reconciliation of external data with EDC data. Perform serious adverse events reconciliation in collaboration with PV. Interact with clinical study team members to resolve database issues and report on the progress of CDM activities. Represent data management on clinical study teams. Use and develop data views for optimal and efficient review of large quantities of data. Leads regular data review activities with the clinical team to ensure accuracy, consistency and reliability of data; may oversee personnel performing data entry, data reconciliation, and data discrepancy resolution tasks. Perform study close out activities working with internal team and/or CRO per project timeline. Ensure data management documentation is appropriated filed in the electronic trial master files. Provides database expertise through attendance at meetings and membership on various committees and teams, as required. Show less



Frontier Science & Technology Research Foundation, Inc. (FSTRF)

• United States
• Research Services
• 100 - 200 Employee

• Lead Clinical Trials Protocol Data Manager

  • May 2014 - 2020

  • SDTM Specialist responsible for creating CDASH compliant forms, annotating forms once built, and modeling SDTM for ongoing study • Collaborate in mapping data from form tables into normalized tables and QA/QC process for transformation • Define specifications for post-processing and formatting necessary to prepare data for SDTM SAS transport files • Assisted SDTM training of protocol data managers, and members of working group on CDISC standards • QA/QC data for REPRIEVE and IRC studies: developed automated logical checks, queried clinical laboratory, treatment, and diagnoses data • Communicated directly with sites regarding monthly/daily QA reports, delinquency listings, and any CRF related questions • Designed visit maps, schedules, paper and electronic Case Report Forms, edit checks, data management listings, and query listings for data cleaning for multiple studies • Developed training materials, and conducted trainings both via web conference and by traveling to site locations • Member of the Monitoring group, tasked with designing monitoring tools for studies currently in development Show less



Eye Care Professionals of Western New York, L.L.P.

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Head Laboratory Technician

  • Jun 2011 - 2020

  • Manager and operator of final stage eyeglass manufacture laboratory • Created operation and inspection protocols • Increased quality standard to 98% error-free • Integrated company transition of Electronic Medical Records into Laboratory • Created tracking system for eyeglasses between offices, organized and implemented ordering processes • Manager and operator of final stage eyeglass manufacture laboratory • Created operation and inspection protocols • Increased quality standard to 98% error-free • Integrated company transition of Electronic Medical Records into Laboratory • Created tracking system for eyeglasses between offices, organized and implemented ordering processes



University at Buffalo

• United States
• Higher Education
• 700 & Above Employee

• Clinical Research Assistant

  • Jul 2012 - Apr 2014

  • Assisted in organization of phase II, III, and IV of clinical trial studies with the Clinical Research Coordinators • Aided in recruiting and enrolling subjects into drug studies, chart reviews, screening of subjects, completing inclusion/exclusion criteria, processing and shipping lab samples • Assisted in obtaining informed consent, formulation and implementation of flow sheets, CRFs, and electronic CRFs • Knowledge of FDA regulations, GCP, and CFR. Experience with local and central IRB regulations and requirements Show less



LensCrafters

• United States
• Retail Apparel and Fashion
• 700 & Above Employee

• Lab Technician

  • Oct 2008 - Jun 2011