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Online Resumes with "ICH guidelines"
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 07042
Summary: * Expertise towards drug development and FDA, GCP/ ICH regulatory guidelines in the pharmaceutical industry Strong experience in a drug development performing different phases of clinical trials and Supported CTH in managing interactions with relevant line functions including Data Management, Drug Supply Management and Novartis Country Organizations and also performed Monitored pre-study, initiation, interim, close...
Tags for this Online Resume: Clinical Research, Research, Oncology, Query, Cardiovascular, Filing, Management, Database, Database Maintenance, DSS
Pharmaceutical Scientist
ver fifteen years of solid experience in pharmaceutical Quality Assurance, Quality Control, Stability, Analytical methods development, Validation, Instrumentation, Lab supervisor and Academic. Accomplished, results-oriented individual with expertise in pharmaceutical area. Extensive hands on experience with HPLC, TLC, GC, TGA, UV/VIS, FTIR, IR, AA, Fluorescence Spectrophotometer and Dissolution. Up-to-date knowledge of cGM...
Ideal Companies: J&J, Celgene, Merck
Tags for this Online Resume: Scientist
Sr. Clinical Research Associate - 22 years Experience - remote - Austin, TX
A top-performing Senior Clinical Research Associate with extensive experience in clinical research, GCP, ICH, Regulatory, and clinical site management/monitoring. Solid background in critical care nursing for in-depth understanding of medical terminology for records review. Highly skilled in spearheading internal teams through clinical research and document management to ensure accuracy and adherence with study specific str...
Ideal Companies: Pharmaceutical, Biotech, Medical Device, CRO
Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Documentation, Medical, Allergy, Monitoring, Reporting Tools, Cardiology, clinical, trial, gcp, protocol, pharmaceutical, regulatory, medical device, CNS, EDC, contract, remote, CRO
Clinical Regional Monitoring - 21 Years of Experience - Near 60031
Over 15 years experience in Clinical Research and Regulatory Study Protocol specifics - ICF's, Inclusion/ Exclusion Criteria, AE/SAE, eCRF's, and SOP Development/Updates * Exceptional attention to detail with strong problem solving skills * Excellent written, verbal and decision making skills * Outstanding interpersonal communication, organization and prioritization skills * Proficient with GCP, ICH guidelines, FDA regulat...
Tags for this Online Resume: Program Manager, Collection, Accenture FOUNDATION, Accounts Payable, Attention to Detail, Billing, Biomedical Industry, Budgeting, Clinical Research, Data Mining
Clinical In-house Monitoring - 17 Years of Experience - Near 08844
10+ years of proficient experience into clinical research as a Clinical research associate in pharmaceutical industries and clinical research organizations. * In-house and regional monitoring experience in Phase I, II, & III. * Capable to work as both in-house CRA and as a Regional CRA with efficiency to monitor and manage any number of sites depending on Sponsor's SOP. * Good working knowledge of GCP and ICH guidelines. (...
Tags for this Online Resume: Research, Clinical Research, Management, Quality, Quality Assurance, Quality Control, Audit, Oracle, Filing, Good Clinical Practices
Biochemist/Quality Manager
I am looking for a challenging position of increasing responsibility in Quality or Research and Development. Trained Biochemist/Molecular Biologist with over 22 years of experience, including 15 years of extensive research and drug development experience in Hematology/Oncology. This includes a diverse set of laboratory techniques and administrative skills. I have had positions of increased responsibility and I was a co...
Ideal Companies: Abbott, Medtronics, Boston Scientific
Tags for this Online Resume: Beta Testing, Filing, Quality Assurance, Audit, research scientist hematology
