Amy Roberts is a highly qualified expert, working in Odonate Therapeutics™ main office of which is in 353. on the position of Associate Director, Data Management since 2019. This expert has earned professional experience in more than 17 positions at various companies. Amy Roberts went to the Boston College and got education there from 2000 to 2004. Phoenixville, Pennsylvania is the city, where this professional was known to be located. The person's contacts can be easily accessed through SoftwareOfficial on demand.
Name variants:
Aimee Roberts,
Amie Roberts
Last updated Jul 01, 2024
Contact Information
Last Update
Jun 27, 2022
Email
am**@gmail.com, am**@gmail.com
Location
Phoenixville, PA
Company
Odonate Therapeutics™
Workplace
Associate Director, Data Management
Work History
Biometrics Project Manager
4130 Parklake Ave SUITE 400, Raleigh, NC 27612
Project Manager overseeing all Biometrics services on Biometrics stand-alone studies. Lead teams across all the data-driven departments and manage the complexity of handling clinical data fr...
Apr 2016 — Jan 2017
Clinical Informatics Manager
4130 Parklake Ave SUITE 400, Raleigh, NC 27612
Jul 2013 — Apr 2016
Lead Data Manager
4130 Parklake Ave SUITE 400, Raleigh, NC 27612
Responsible for oversight and management of design, development and conduct of Phase I/II oncology (HL), Phase I oncology (breast), Phase Ib/IIa Hepatitis C, and Phase III Traumatic Brain In...
Jul 2012 — Jun 2013
Senior Clinical Data Management Consultant
1400 Atwater Dr, Malvern, PA 19355
Performed critical review of company documents and procedures identifying inefficiencies and divergences from industry standards and/or FDA guidances. Revised existing documents and procedu...
Sep 2011 — Apr 2012
Senior Quality Control Coordinator and Statistical Assistant
1 Park Dr SUITE 150, Durham, NC 27709
Assisted statisticians by creating datasets, tables, listings, and figures for both interim and final analyses, liaising with Medical Writers as necessary
Developed specifications for anal...
Mar 1998 — May 2001
Research Specialist Ii
Served as Study Coordinator for human gene therapy clinical trials through data retrieval and warehousing. Performed experiments to test immunological function of trial patients that include...
1996 — Mar 1998
Education
2000 — 2004
1993 — 1997
Occupations
Executive
Deputy Director
Scientist
Biotechnology Professional
Senior Manager
Deputy Manager
Chief Executive
Biologist
Biological Scientist
Operations Manager
Skills
Clinical Data Management
Clinical Trials
Oracle Clinical
Ctms
Oncology
Data Management
Pharmaceutical Industry
Project Management
Crf Design
Gcp
Clinical Development
Inform
Budget Management
Clinical Research
Edc
Budget Forecasts
Budgets
Protocol
Regulatory Affairs
Fda
Technical Leadership
Cdisc
21 Cfr Part 11
Medidata
Clinical Monitoring
Ich Gcp
Validation
Sop
Medical Writing
Databases
Budget Monitoring
Therapeutic Areas
Sas
Pharmaceuticals
Product Management
Management
Cross Functional Collaborations
Partner Management
Sql
Clinical Trial Management
Neurology
Clinical
Computer System Validation
Financial Services
Services