Michelle Gottlieb, LLC

**** ******** ** • Bel Air, MD 21015 • 201-***-**** • ad3pn9@r.postjobfree.com

PROFILE

Qualified clinical research professional with quality control (QC) and editing, medical writing, and data management experience in pharmaceutical, medical device, and not-for-profit research companies in multiple therapeutic areas including oncology, rare diseases, neurology, immunology, and orthopedics with a B.A. degree specializing in business communications, an A.S. degree in business administration, and a Medical Terminology/Transcription certificate.

PROFESSIONAL EXPERIENCE

PTC Therapeutics, Quality Control (QC) and Editing Consultant March 2023-present

Provide QC and editing of clinical and nonclinical documents including protocols, clinical study reports, interim data reports, summaries of clinical safety/efficacy, pharmacology written summaries, etc.

Ludwig Institute for Cancer Research, Assistant Medical Writer January 2017-December 2022

Assisted in writing, editing, and quality control (QC) for clinical trial documents including clinical study reports (CSRs), subject narratives, manuscripts, protocols, abstracts, development safety update reports (DSURs), etc. for multiple studies in cancer research. Part-time Consultant January 2017-July 2018, Part-time Employee July 2018 to December 2022.

• Wrote and edited subject narratives and CSR shells for multiple studies.

• Performed detailed QC of CSRs, DSURs, subject narratives, manuscripts, abstracts, protocols, and submissions posted on the ClinicalTrials.gov protocol registration and results system.

• Reviewed abstract submissions and presentations for several oncology organizations and conferences.

TACA, Volunteer Parent Mentor September 2013-present

Educate and coach parents of children with autism for a not-for-profit autism organization.

Novartis Pharmaceuticals Corporation, Assistant Data Manager December 2007-May 2008

Performed data management and data review functions within the Neuroscience division. Contracted through MedFocus LLC and hired by Novartis.

• Managed clinical data for multiple studies.

• Analyzed and reviewed data within the Novartis electronic data capture (EDC) system.

• Resolved data discrepancies and wrote queries to the site for further clarification.

Stryker Orthopaedics, Clinical Data Coordinator January 2007-November 2007 (Consultant), August 2005-March 2006

Researched, resolved, and managed orthopedic and radiographic data for multiple clinical studies.

• Generated queries, resolved data discrepancies, assisted in creation of edit specifications, and coded adverse events.

• Designed Case Report Forms (CRFs) and Data Clarification Forms (DCFs) and analyzed data reports for CRF/x-ray process flow; participated in physician-led x-ray reviews and Investigator meetings.

Ikaria (formerly INO Therapeutics), Clinical Data Associate June 2006-September 2006

Performed discrepancy management using Oracle Clinical and managed clinical data for multiple studies for the Clinical Research department of a rising respiratory care company in the pharmaceutical industry.

Abbott Laboratories, Clinical Data Entry Technician/Administrative Assistant May 2000-May 2003

Promoted to clinical data management within the Biostatistics and Data Management department of a major pharmaceutical and medical device company. Trained new employees on clinical data entry guidelines.

EDUCATION

Rutgers University Medical Terminology/Transcription Certificate 2007 96.79%

Ramapo College of New Jersey B.A., Contemporary Arts 2006 3.86 GPA (4.0 scale) (Specialization - Business Communications)

County College of Morris A.S., Business Administration 2004 3.76 GPA (4.0 scale)

HONORS

National Chancellor’s List 2005-2006

National Dean’s List 2004-2005

Dean’s List, Ramapo College of New Jersey 2004-2005 Dean’s List, County College of Morris 2004

Phi Theta Kappa honor society, County College of Morris 2004

DATABASE EXPERIENCE AND TRAINING

MS Office, Adobe Acrobat, Oracle Clinical, Oracle Discoverer, Globos Clinical Research Database, SAS, Adobe PageMaker (CRF/DCF Design), Dictaphone. Grammar/Proofreading and Business Writing and Editing Training.

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