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NAMSA - Senior Medical Research Manager Resume Example

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SENIOR MEDICAL RESEARCH MANAGER
Professional Overview
Study Director that is experienced in conducting nonclinical safety studies for evaluating product safety. *Serves as the single point of control to oversee all aspects of nonclinical safety studies. *Exchanges information with professionals from other disciplines and at different levels in order to collaborate efficiently. *Manages time efficiently to coordinate multiple studies (simultaneously) and demonstrates excellent communication skills in written and oral media.
Core Qualifications
Microsoft Office Suite, National Center for Biotechnology Information (NCBI), EndNote, VectorNTI, Statistical Package for the Social Sciences (SPSS), AxioVision, Cell Quest
Education
Doctor of Philosophy (PhD) : Molec. and Cell. Biology, 2006 Medical College of Ohio － Toledo, Ohio Molec. and Cell. Biology
Bachelor of Science (BS) : Biology, 2000 Bowling Green State University － Bowling, Ohio Biology
2014 American College of Toxicology － Gaithersburg, Maryland Clinical Pathology Training Workshop - 2011, Global Preclinical Training, Lake Tahoe, California Study Director Training Workshop - 2011, Global Preclinical Training, Lake Tahoe, California Exp. Genetics of the Lab. Mouse in Cancer Res. - 2001, The Jackson Laboratory, Bar Harbor, Maine
2013 WILCARE (Use of Animals in Nonclinical Studies)-Module II: Toxicology, WIL Research, Ashland, OH. 2012 WILCARE (Use of Animals in Nonclinical Studies)-Module II: Toxicology, WIL Research, Ashland, OH. 2008 DNA Repair and Radiation Oncology Group : 2008 UT Southwestern Medical Center Cancer Track Works － Dallas, TX.
2007 DNA Repair and Radiation Oncology Group UT Southwestern Medical Center － Dallas, TX.
M.D., Ph.D : 2005 UT Southwestern Medical Center － Dallas, TX. Hosted by Woodring Wright
Ph.D : 2005 University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center University of Miami － Chapel Hill Miami, NC. FL. Hosted by Jack Griffith, Ph.D. 2005 Invited Speaker, The Rockefeller University, New York, NY. Hosted by Titia de Lange, Ph.D. 2005 Invited Speaker, Stowers Institute, Kansas City, MO. Hosted by Peter Baumann, Ph.D. 2004 Annual Miami Nature Biotechnology Winter Symposium
Sixth Annual Midwest DNA Repair Symposium : 2004 University of Kentucky － Lexington, KY.
2004 Larry E. Gentry Fall Student Research Forum, Medical College of Ohio － Toledo, OH.
2003 Medical College of Ohio － Toledo, OH. Molecular and Cellular Biology Seminar Series
2002 Larry E. Gentry Fall Student Research Forum, Medical College of Ohio － Toledo, OH.
Experience
Senior Medical Research Manager
July 2013 to Current NAMSA － Northwood, Ohio
  • Medical Research Managers Direct nonclinical safety studies that are 1) designed in accordance with ISO-10993 guidelines and 2) are compliant with the US FDA Good Laboratory Practice (GLP) Standards.
  • Actively communicate with Sponsors during the development of study protocols and protocol amendments, during the in-life portion of the study, and during the report writing stage.
  • Design non-standard surgical studies to evaluate medical device biocompatibility and functionality.
  • Direct non-standard analytical chemistry studies to determine leachables of product components.
  • Exceptional study management skills to coordinate departmental responsibilities within the organization and with external subcontractors for the performance of safety studies.
  • Perform the planning of the study as well as the analysis, interpretation, documentation, and reporting of results.
  • Work together with the Quality Assurance Department to ensure that studies are compliant with the applicable GLP Standards and to respond to audit findings.
March 2011 to July 2013 WIL Research － Ashland, Ohio
  • Toxicologist (Study Director), General Toxicology Directed nonclinical toxicology studies that are compliant with the US FDA Good Laboratory Practice (GLP) Standards, US EPA GLP Standards, and/or the OECD Principles of Good Laboratory Practices.
  • Conducted acute, dose range-finding, subchronic, immunotoxicity, and chronic toxicology studies in mice, rats, dogs, and non-human primates.
  • Actively communicated with Sponsors during the development of study protocols and protocol amendments, during the in-life portion of the study, and during the report writing stage.
  • Exceptional study management skills to coordinate departmental responsibilities within the organization and with external subcontractors for the performance of toxicology studies.
  • Performed the planning of the study as well as the analysis, interpretation, documentation, and reporting of results.
  • Worked together with the Quality Assurance Department to ensure that studies are compliant with the applicable GLP Standards and to respond to audit findings.
  • Collaborated with the business development team to draft and review study proposals for accurate costing (and to update study costs, based on protocol amendments).
January 2008 to January 2010
  • Ruth L.
  • Kirschstein National Research Service Award (F32 NRSA, NIH).
  • 2007 - 2008: Cancer Biology Training Grant (T32, NIH / UT Southwestern).
  • Compiled, analyzed, and interpreted experimental results.
  • Prepared data for oral presentations, manuscripts (publications), and grant applications.
  • Presented results / represented our laboratory at international conferences and meetings.
Postdoctoral Research Fellow
April 2006 to February 2011 University of Texas Southwestern Medical Center － Dallas, Texas
Publications
Phillip G. Smiraldo, Jun Tang, Jerry W. Shay, and Woodring E. Wright. Cellular Senescence, Telomerase, and Cancer in Human Cells. Book Chapter Appearing in 'Telomerases: Chemistry, Biology, and Clinical Applications'. John Wiley & Sons, Inc., 2012. Phillip G. Smiraldo, Aaron M. Gruver, Joshua C. Osborn, and Douglas L. Pittman. Extensive Chromosomal Instability in Rad51d-Deficient Mouse Cells. Cancer Research 65(6): 2089-2096, 2005. Highlighted cover article. Aaron M. Gruver, Kristi A. Miller, Changanamkandat Rajesh, Phillip G. Smiraldo, Saravanan Kaliyaperumal, Rachel Balder, Katie M. Stiles, Joanna S. Albala, and Douglas L. Pittman. The ATPase motif in RAD51D is required for resistance to DNA interstrand crosslinking agents and interaction with RAD51C. Mutagenesis, 20:433-440, 2005.
Skills
Biology, Biotechnology, business development, Cancer, chemistry, oral, conferences, costing, DNA, documentation, Genetics, GLP, Good Laboratory Practices, Good Laboratory Practice, grant applications, interpretation, ISO, Director, management skills, meetings, Microsoft Office Suite, Oncology, Pathology, presentations, proposals, protocols, Speaker, publications, Quality Assurance, Quest, report writing, reporting, Research, safety, SPSS, Symposium
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Resume Overview

Companies Worked For:

School Attended

  • Medical College of Ohio
  • Bowling Green State University
  • American College of Toxicology
  • UT Southwestern Medical Center Cancer Track Works
  • DNA Repair and Radiation Oncology Group UT Southwestern Medical Center
  • UT Southwestern Medical Center
  • University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center University of Miami
  • University of Kentucky
  • Larry E. Gentry Fall Student Research Forum, Medical College of Ohio

Job Titles Held:

  • Senior Medical Research Manager
  • Postdoctoral Research Fellow

Degrees

  • Doctor of Philosophy (PhD) : Molec. and Cell. Biology , 2006
    Bachelor of Science (BS) : Biology , 2000
    2014
    2013 WILCARE (Use of Animals in Nonclinical Studies)-Module II: Toxicology, WIL Research, Ashland, OH. 2012 WILCARE (Use of Animals in Nonclinical Studies)-Module II: Toxicology, WIL Research, Ashland, OH. 2008 DNA Repair and Radiation Oncology Group : 2008
    2007
    M.D., Ph.D : 2005
    Ph.D : 2005
    Sixth Annual Midwest DNA Repair Symposium : 2004
    2004
    2003
    2002

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