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Online Resumes with "phase I III"
Clinical Research
PROFESSIONAL SUMMARY: Experienced Clinical Research Professional seeking career advancement with a CRO where I can make a positive contribution by utilizing my clinical research expertise. In-depth knowledge of clinical trial policies and procedures, study protocols, GCP guidelines, ICH guidelines, regulatory clinical trial documentation requirements, IRB documents submittal, sponsor electronic data capture systems for data...
Tags for this Online Resume: Chemotherapy, Clinical Research, Collection, Gastrointestinal, Oncology, PEDIATRIC, Protocol, Support
Clinical Research - 20 Years of Experience - Near 30016
SUMMARY * 23 years as a Clinical Data Management working for the following companies: Novartis, PRA International, Abbott, Covidien, Ingenix (i3), Ortho Clinical Diagnostics, Octagon Research Solutions and Pharmanet i-3. * 20+ years' experience of team leadership working with: Data Manager, Clinical Data Coordinator (CDC), Data Entry Personnel, Biostatisticians, Programmers, Investigators and Clinical Research Associates (C...
Tags for this Online Resume: clinical , Data, Manage , Reasar, Data Manager, Query, Coding, Quality Assurance, Test, Medical, Audit, Clinical Research
Educational Administrator
Tags for this Online Resume: Security, Training, Communication Skills, Documentation, Leadership, Management, Microsoft, Microsoft Office, Process Improvements, Program Management
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Environmental, Health & Safety Manager - 0 Years of Experience
Extensive experience across many industrial sectors including industrial and manufacturing, municipalities, colleges and universities, and commercial sectors Good Problem Solver & Works Well Under Pressure Audit Development and Management Exceptional Knowledge of OSHA, EPA, and DOT Industrial Hygiene Sampling for Lead, Noise, regulations Isocyanates, Respirable Dust Excellent Computer Skills Phase I/II Environmental Site A...
Tags for this Online Resume: Management, Assessments, Audit, Compensation, Compliance, Corporate Training, D.O.T., Help Desk, HYGIENE, Information Technology
