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Online Resumes with "ICH "
Biostatatician - 18 Years of Experience - Near 07059
Experienced with IND/NDA submissions, and knowledgeable in regulatory guidelines (ICH), 21 CFR Part11 and Good Clinical Practice (GCP). * Highly experienced in clinical protocol development, experimental design, sample-size and power calculation, randomization, and study analysis planning (SAP). * Proficient in SAS/Base, SAS/Stat, SAS/Graph, SAS/Macro and SAS/ODS. * Skillful in data validation data manipulation, graph, tabl...
Tags for this Online Resume: Health Care Industry, clinical, protocol, sas, pharmaceutical, sap, ich, gcp, trial, phase, oncology
Registered Nurse - 15 Years of Experience - Near 60030
SUMMARY OF EXPERIENCE * Monitored Phases I, II, III, clinical trials in many therapeutic areas, including, but not limited to, Oncology, Cardiology, Dermatology, Infectious Diseases, Immunology, Women's Health, Gastrointestinal, Genitourinary, Neuroscience, in Adult and Pediatric (Otitis Media and Influenza) populations. * Managed multiple studies in various stages of conduct at as many as 15 study centers at any given time...
Tags for this Online Resume: Cardiology, Clinical Research, Dermatology, Gastrointestinal, Good Clinical Practices, ICH, Immunology, Infectious Diseases, Monitoring, Oncology
Clinical Research - 1 Years of Experience - Near 20111
Highlights of Qualifications Self-disciplined, self-confident and goal oriented Effective both working independently or in a team environment Excellent analytical skills and scientific reasoning Responsible and works well under pressure Possess effective organizational, communication, presentation and interpersonal skills. Effective decision-making and problem resolution skills. Hardworking and Work History
Tags for this Online Resume: Analytical Skills, Autodesk, Autodesk Inventor, CAD Tools, Data Entry, Design Cad, Good Clinical Practices, ICH
Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 10591
To obtain a position as a Drug Safety Associate.
Ideal Companies: Regeneron, Pfizer, HHC NYC
Tags for this Online Resume: Distribution, Training, Data General Nova, Chemistry, High Performance Liquid Chromatography (HPLC), PEDIATRIC, Inventory, Inventory Control, Cancer, Chemotherapy, oncology, clinical, pharmaceutical, gcp, ich, protocol, phase, sas
Medical Scientist - 14 Years of Experience
Profile: Professional in Clinical Research with Extensive Medical Knowledge and Academic Research Experience Summary of Qualifications Clinical Research Skills * Graduated with Master Degree in Clinical Investigation Sciences, with knowledge and experience in clinical research, clinical trials design, IRB application, informed consent writing, protocol design, and data analysis. As well as knowledge in epidemiology and publ...
Tags for this Online Resume: Cardiology, Progress, Research, Cardiovascular, Medical, Consulting, Data Analysis, Pediatrics, Training, Attention to Detail
Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440
Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...
Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality
Clinical Research - 10 Years of Experience - Near 80002
Tags for this Online Resume: Payroll, Direct Patient Care, Patient Care, Data Entry, ICH, Protocol, Clinical Research, Project Management, Project Manager, Research, phase ii, Phase i, Phase iii, Phase iV, Clinical Trials, Pharmaceutical, Orthopedics, Regulatory
General - 7 Years of Experience
KEY QUALIFICATIONS: * COMPLAINTS & TECHNICAL SUPPORT SPECIALIST WITH 5+ YEARS OF PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRY experience * 5+ years of experience with product complaints including experience with Global Customer Complaints (GCC), adverse events, and auditing of complaint records * Excellent knowledge of quality standards and regulations: FDA QSR 21 CFR 803 & 820, ISO Standards 9001 / 13485 / 14971, MDD 93/42/E...
Tags for this Online Resume: Complaints, Good Clinical Practices, Medical, Pharmaceutical, Support, Technical Support, Clinical Research, Project Management, Project Manager, Research
Clinical Regional Monitoring - 17 Years of Experience - Near 46321
SUMMARY OF CLINICAL EXPERIENCE Eleven years' experience as a CRA which includes 2 years as a Lead CRA in clinical trial monitoring, including study start up, study initiation through closeout, as well experience in International, and Domestic studies. Provide on-site clinical trial monitoring and full site management at investigational sites in the conduct of Phase II-IV clinical trials. Recruited and trained CRA (s), inves...
Tags for this Online Resume: Data Management, Gastroenterology, Management, Patient Education, Pharmaceutical Industry, Start up, Clinical Research, Research
Clinical Regional Monitoring - 20 Years of Experience - Near 18929
Seeking an opportunity with a Pharmaceutical, Biotechnology company or CRO as a Senior Lead Clinical Research Associate, Lead CRA, CRA Manager/Trainer (Mentor) and/or CRO Oversight Monitor to employ my 27 years of clinical research monitoring, management skills and CRA mentoring as well as19 years of Respiratory/Pulmonary and Cardiopulmonary critical care clinical medicine. Clinical Research Experience: Projects/Therapeutic...
Tags for this Online Resume: Pharmaceutical, Clinical Research, Research, Rheumatology, Biomedical Industry, Pharmaceutical Industry, Cardiology, Critical Care - Neurology, Critical Care - Respiratory, Neurology, oncology, clinical, phase, gcp, protocol, trial, ich
Clinical Quality Assurance - 15 Years of Experience - Near 02139
Tags for this Online Resume: pharmaceutical, ich, gcp, Audit, Complaints, Distribution, Management, Manufacturing, Packaging, Quality
Medical Scientist - 19 Years of Experience - Near 20124-2466
Tags for this Online Resume: Research, Chemistry, Medical, Medical Terminology, Science, English Language, protocol, trial, phase, oncology, sas, pharmaceutical, clinical, ich, sap, gcp
