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Biometrics Business Operations Lead Resume Example

Resume Score: 80%

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BIOMETRICS BUSINESS OPERATIONS LEAD
Professional Summary

Clinical Data Manager (CDM) with oversight of two studies, at a small biotech, working on T-cell therapies in Oncology. Responsible for developing SOP's, Data Standards, and site training materials. Adept at managing databases and ensuring proper collection of key data points, including CRO oversight of Data Management activities, from study start-up to post database lock activities. Skilled in Public Health, Clinical Research and Data Analysis.

Skills
  • SAS, SPSS, Microsoft Office, IBM Clinical Development, Medidata Rave
  • Continuous learning in Clinical R & D, Programming, Data review, Project coordination, and Oncology
  • Fluent in French and conversant in Spanish
  • Experience in IRB submission and HIPAA compliance
Education
Doctor of Public HealthCapella University - Minneapolis, MNExpected in 05/2023
Master of Public Health (M.P.H): Community HealthArcadia University - Glenside, PA05/2018
Bachelor of Science: Biobehavioral HealthThe Pennsylvania State University - University Park, PA05/2015

Minor in Sociology

Industry Experience
Biometrics Business Operations LeadAdaptimmune LLC - Philadelphia, PA04/2020 - Current
  • Develop timelines and lead internal and external actions, and resources supporting data management activities on multiple historical and contemporary oncology trials
  • Create and expand data management activities and processes in adherence to ICH guidelines
Clinical Data ManagerAdapimmune LLC - Philadelphia, PA01/2019 - Current
  • Responsible for Clinical Data Management CRO oversight
  • Lead Data Management activities and ensure study deliverables meet timelines and quality standards
  • Develop Case Report Form Completion Guidelines and Data Review Plan; Design case report forms (CRFs) to capture all protocol mandated data points
  • Participate in review and QC of protocols and amendments across indications for consistency of biomarker collection and data management activities
  • Assure quality data through review and approval of documentation (Data Management Plan, Coding Plan, and Edit Checks)
  • Routinely report to study team on Data Management activity (EDC status and CDM timelines)
  • Facilitate data cleaning activities including data review and query generation for assigned protocols
  • Reconcile discrepancies between clinical and serious adverse events (SAE) databases
  • Identify, test, document, and run electronic edit checks; Complete user acceptance testing (UATs) of new and updated databases
  • Work directly with multidisciplinary teams to drive project results
  • Mentor junior level staff on all associated tasks within a study
  • Execute study close out activities
  • Mentor junior level staff on all associated tasks within a study
  • Support DM team as needed
Graduate Research StudentArcadia University - Glenside, PA08/2016 - 08/2018
  • Gathered, arranged and corrected research data to create representative graphs and charts highlighting results for presentations.
  • Took active role in departmental meetings, engaging with all parties and transcribing detailed notes of plans, decisions and options discussed.
  • Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.
  • Performed in-depth interviews with research subjects and compiled data and analyses into reports for review by group leader.
  • Disseminated research findings to various personnel in different formats, including white papers, presentations and spreadsheets.
  • Supported design and implementation of survey instruments such as telephone questionnaires to obtain study information.
  • Developed macros, special formulas and other actions to produce reliable and consistent statistical reviews.
  • Performed routine data analysis to correct and verify data entry.
Community Development

Community Volunteer Mayanza Non-Profit Organization

  • International Inter-Professional Education Experience in Santiago Atitlan, Guatemala
  • Provide health screenings to over 500 school children in Santiago Atitlan, Guatemala
  • Convey health information and education to parents and school-teachers in English and Spanish
  • Provide resources to continue the health teachings of Mayanza throughout the school year
Certifications

Epidemiology in Public Health Practice by Johns Hopkins University on Coursera. Certificate earned at 04/21/2020

Affiliations

2019: Penn State University - HHD Alumni Mentorship Program | Society for Clinical Data Management

2018: The Wallace E. Young Community Service Public Health Award | American Public Health Association

2017: Community Health Training Alliance | Public Health Young Leaders Association

2011: The Gates Millennium Scholars Foundation

Publications

Collaborative writer for the American Public Health Association (APHA) International Health Section Summer Blog Series, "Intimate Partner Violence: Global Burden, Risk Factors and Outcomes."

Romulus E. (2018, April). Examining the Influence of Literacy on Contraceptive Knowledge and Use among Women in Swaziland. Presented at the Global Health & Innovation Conference, Yale University, CT.

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Resume Overview

Companies Worked For:

  • Adaptimmune LLC
  • Adapimmune LLC
  • Arcadia University

School Attended

  • Capella University
  • Arcadia University
  • The Pennsylvania State University

Job Titles Held:

  • Biometrics Business Operations Lead
  • Clinical Data Manager
  • Graduate Research Student

Degrees

  • Doctor of Public Health
    Master of Public Health (M.P.H) : Community Health
    Bachelor of Science : Biobehavioral Health

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