2013 -2014 Senior Director, Operations and Recruitment Lead Consultant | Elan Pharmaceuticals @
2009 -2013 Director Clin Ops Program Lead; Head of Quality Management and Compliance R and D Operations @
2007 -2009 Associate Director Clinical Operations @
2003 -2007 Senior Principal Program Manager | PPD @
2001 -2003 Lead CRA (Clinical Research Associate) | Teva Pharmaceuticals @
1999 -2001 Senior QA Auditor | IQVIA (contracted by The Lewin Group) @
1997 -1999 Senior CRA | Noven Pharmaceuticals @
1995 -1997 Director, Outpatient Movement Disorder Research Clinic | Mount Sinai @ https://www.mountsinai.org/
1993 -1995 Senior Regional Clinical Research Associate | Regeneron @
1991 -1993 Clinical Research Manager; Clinical Research Associate @ Health and Sciences Research (HSRI)
1981 -1991 Registered Nurse Critical Care, Neurosciences and Clinical Research @ https://www.nyp.org/
Debbie Cote Education
Dominican College of Blauvelt 1982-1984
Dominican University New York 1982-1984
Debbie Cote Skills
FDA
CRO
Sop
Pharmaceutical Industry
Regulatory Submissions
GCP
Clinical Research
EDC
CTMS
Clinical Trials
Biotechnology
Clinical Development
Oncology
21 CFR Part 11
SDLC
Regulatory Affairs
GxP
Clinical Data Management
Drug Development
Infectious Diseases
Clinical Operations
Pharmacovigilance
Lifesciences
IND
Medical Devices
Protocol
Validation
Clinical Monitoring
ICH-GCP
GLP
Therapeutic Areas
Vaccines
Neurology
Quality Assurance
CAPA
Oracle Clinical
Phase I
Cross-functional Team Leadership
Biopharmaceuticals
Quality System
Healthcare
Clinical Study Design
Drug Safety
R&D
Quality Management
Neuroscience
Drug Discovery
Central Nervous System
Assurance and Compliance
Integrated Risk Management
Strategy
Leadership
Inspection Readiness
Program Management
Customer Service
Readiness
Operations
Development
Regulatory
Cross Functional Team Leadership
Inspection
Planning
Management
Ich Gcp
Cross Functional Team
Microsoft Office
Operational Excellence
Integrated Risk
Microsoft Excel
Strategic Planning
SQL
Debbie Cote Summary
Debbie Cote, based in California, United States, is currently a Principal and Executive Consultant, Clinical Operations and Development Strategy at CoteClinical Advisors. Debbie Cote brings experience from previous roles at Apexigen, CoteClinical Advisors, Eureka Therapeutics, Inc and Nektar Therapeutics. Debbie Cote holds a 1982 - 1984 Dominican College of Blauvelt. With a robust skill set that includes FDA, CRO, Sop, Pharmaceutical Industry, Regulatory Submissions and more. Debbie Cote has 2 emails and 4 mobile phone numbers on RocketReach.
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