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clinical research manager resume example with 10+ years of experience

JC
Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
Professional Summary

Clinical Research Professional with more than 7 years of research experience specializing in interventional oncology treatments and medical devices. Well0versed in ICH/GCP regulations, study start-up, IRB and regulatory procedures, coordinator management, and other clinical trail related procedures. Experience in project management, working in high-paced environment across multi-disciplinary teams.

Skills
  • Extensive knowledge of FDA regulations and Good Clinical Practices
  • Clinical Trails Management
  • Experienced in Microsoft Suite, Google Suite, Smartsheets
  • Data visualization: Tableau
  • Project management: JIRA, Waffle, Github
  • CITI Certified
  • Regulatory Management
  • Analytics and database management: SQL, Google Analytics
  • Prototyping: Balsamiq, Axure
  • Languages: Spanish
Work History
03/2019 to Current Clinical Research Manager Envista | Charleston, SC,
  • Lead the Gastrointestinal Oncology and the Molecular Targeted Therapy clinical research programs.
  • Directly manage 12 coordinators as well as work closely with physicians, the Stanford Cancer Institute leadership team, and Stanford Healthcare clinics to manage a portfolio of 30+ Phase I-III studies
  • Oversee all operational aspects in GI Oncology and Molecular Targeted Therapies for the implementation of clinical trial activities from study start-up through database lock, ensuring Good Clinical Practices (GCPs) and relevant Standard Operating Procedures (SOPs) are met.
  • Review monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data is delivered; coordinate with Contract Research Organizations (CROs) on site selection, Institutional Review Board (IRB) submissions, site initiation and close-out planning.
  • Communicate directly with study site staff and investigators for clinical trials; track patient recruitment and progress to study timelines; support safety reporting and IRB submissions; maintain and report metrics for clinical site performance.
  • Manage finances for the clinical research group, including budget development for industry sponsored studies, federally funded studies, and investigator initiated studies.
01/2015 to 02/2019 Clinical Project Manager Merit Medical Systems, Inc. | Providence, RI,
  • Managed all major clinical projects for a Medical Device company, providing guidance to cross-functional team (product, marketing, and design) to ensure timely execution and proper distribution of results.
  • Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, creation of study related documents (including protocols, case report forms, Informed consents, Clinical trial agreements), organizing IRB/EC submissions with follow through to ensure successful outcome
  • Identified opportunities to improve clinical practices, devised strategies and implemented plans to increase patient care standards and enhance operational procedures.
  • Established strategic plans and objectives for national and global clinical programs and projects, such as self-funded studies and outside grants.
  • Work with a cross-functional team (data science, engineering, sales) to define and prioritize product features and support end-to-end implementation of new product features, including digital therapeutics and medical devices
10/2012 to 12/2014 Medical Operations Specialist Nextcare, Inc. | Bixby, OK,
  • Increase physician and patient engagement by analyzing feedback, observing consumers and collecting surveys.
  • Generated reports of findings to help management with making key decisions for product changes and development.
  • Analyzed and reported on health policy changes and researched potential partnerships to present to the CEO and senior leadership for growth opportunities
Education
Expected in 2012 Master of Science | Global Health And Anthropology University of Edinburgh, Edinburgh Scotland, GPA:
  • Thesis: Thesis: Effects of the oral polio vaccination boycott in northern Nigeria on the progress towards polio eradication. Post Graduate Diploma in Infectious Diseases. Advanced coursework in Epidemiology, Health Policy, Health Economics, and Program Management.
Expected in 2010 Bachelor of Arts | Interdisciplinary Studies in Culture Scripps College, Claremont, CA GPA:
  • Thesis: Where are the women? Examining the historical marginalization of women and their consequential absence in contemporary HIV/AIDS discourse in Mexico. Advanced coursework in Medical Anthropology and Gender Studies.

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Resume Overview

School Attended

  • University of Edinburgh
  • Scripps College

Job Titles Held:

  • Clinical Research Manager
  • Clinical Project Manager
  • Medical Operations Specialist

Degrees

  • Master of Science
  • Bachelor of Arts

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