
Amy Neubauer
Leader with more than 15 years of experience in clinical research and a talent for mentoring staff. ... | Uxbridge, Massachusetts, United States
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Amy Neubauer’s Emails am****@al****.com
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Amy Neubauer’s Location Uxbridge, Massachusetts, United States
Amy Neubauer’s Expertise Leader with more than 15 years of experience in clinical research and a talent for mentoring staff. Expertise in risk-based study execution, clinical data standards, clinical data management, project management, and vendor management, and am an experienced auditor of clinical vendors and data management systems with expert-level knowledge of the various data management systems and complicated integrations. Throughout my career, I have led cross-functional teams focused on process improvement, recently leading a workstream to design a new vendor onboarding process with input from stakeholders in Clinical Quality, Validation, Info Sec, Purchasing, and Legal that addressed significant challenges in cross-communication, documentation requests, disparate risk assessments, and improved the experience and timeline for external partners and internal business leads. I continue to serve my greater community by speaking at conferences and through my work with the Society of Clinical Data Management. I also serve on the publications committee, which in 2021, launched a new peer-reviewed journal (jscdm.org) that met the requirements to apply for indexing with the final quarterly publication in 2021. Clinical experience in CNS (schizophrenia, bipolar, major depressive disorder (MDD), multiple sclerosis (MS), addiction), vaccines, medical devices (including surgical, diagnostics, and medical imaging), oncology and immuno-oncology (solid tumor, renal cell carcinoma, melanoma, and multiple myeloma, using RECIST and iRECIST), anti-infectives, transplant, and rare genetic disorders including childhood cerebral adrenoleukodystrophy (CCALD) and Duchenne muscular dystrophy (DMD).
Amy Neubauer’s Current Industry Alexion Pharmaceuticals
Amy
Neubauer’s Prior Industry
Clinivation
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Veristat
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Hologic
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Alkermes
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Alexion Pharmaceuticals
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Work Experience

Alexion Pharmaceuticals
Director, GCDM Operational Excellence
Fri Jul 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Alkermes
Director, Data Quality Oversight
Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jun 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Alkermes
Associate Director, Technical Solutions
Wed Feb 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Alkermes
Associate Director, Data Management
Mon Dec 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Feb 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Hologic
Manager, Clinical Data Management
Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Nov 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Veristat
Assoc. Dir., Clinical Operations - Data Management
Tue Mar 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Veristat
Manager, Program Operations
Wed Oct 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Veristat
Sr. Clinical Data Manager
Tue Aug 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Oct 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Clinivation
Data Manager
Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)