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Online Resumes with "ICH"
Pharmacokinetist
Tags for this Online Resume: Pediatrics, Research, Allergy, PEDIATRIC, Sar, High Performance Liquid Chromatography (HPLC), phase, trial, gcp, protocol, pharmaceutical, ich, DMPK, pharmacokinetics, ADME
Animal Scientist - 20 Years of Experience - Near 19129
with Animal Surgery Province, Southwestern Minority -Teaching and research focussed on Endocrinology using radio immunoassay.
Tags for this Online Resume: Electrophoresis, ELISA, Research, Mcp (Os -Lg Unisys Sys), Medical, Project Management, Project Manager, Surgery, oncology, clinical, phase, trial, gcp, protocol, sas, pharmaceutical, sap, ich, animal surgery, mice, rats, cell culture, iPS cell, myocyte, mouse models of heart attack, heart feilure model
Clinical Research - 16 Years of Experience - Near 94547
SUMMARY of QUALIFICATIONS 16 years of experience as a Clinical Research professional in Biotech and Pharmaceutical industries. Well-rounded skill, as a CRA in Clinical Operations processes, Clinical Development, Regulatory, TMF and Data Management. Skilled in data audit/review Study start up, Study conduct, Vendor management, and Site monitoring activities extensive knowledge of GCP-ICH, GLP, GMP guidelines familiar with Ex...
Tags for this Online Resume: Protocol, Assessments, Audit, Clinical Research, Documentation, Pediatrics, Research, Clinical Management, Distribution, oncology, phase, trial, clinical, protocol, pharmaceutical, gcp, ich
Clinical In-house Monitoring - 4 Years of Experience - Near 95131
Tags for this Online Resume: Documentation, Protocol, Audit, Good Clinical Practices, ICH, Management, Quality Assurance, Test, Quality, Quality Control, oncology, clinical, phase, trial, gcp, protocol, pharmaceutical, SOP, CAPA, Regulation, ich, Monitor, Clinical research, Clinical Trial
Pharmacist - 2 Years of Experience - Near 30338
To be an astute learner and best performer in building an innovative career in your esteemed organization using my skills and work enthusiastically in team to achieve goal of the organization with devotion and hard work.
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quality Assurance, Research, Test, Apple MacIntosh Operating System, Good Manufacturing Practices, ICH, Microsoft Office, Microsoft Windows XP, Spectrophotometer, Quality assurance/ validation
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Clinical Regional Monitoring
Therapeutic experience in IVD Oncology Hematology Orthopedics GI Cardiology Melanoma ENT Multiple Sclerosis and ADHD Extensive knowledge of FDA regulations ICH guidelines GLPs GCPs and SOPs * Monitoring experience of national and international sites for PSSVs SIVs IMVs and COVs * Ability to identify issues and resolve appropriately * Experience multiple EDC systems and platforms
Tags for this Online Resume: Accounting, Policies and Procedures, Project Management, Project Manager, Protocol, Documentation, Cardiology, Clinical Research, Orthopedics, Research
Clinical Research - 3 Years of Experience - Near 02478
Summary: MS in Clinical Investigation with 3+ years of experience as Clinical research assistant cum coordinator seeking a preferably full time position in Clinical Research fields as Clinical Trial Associate / Project Management. Offering combination of strong background in biological sciences (specialization in Oncology, Molecular biology) as well as deep understanding and knowledge of ICH-GCP & FDA regulations. Demonstra...
Tags for this Online Resume: Clinical Research, Documentation, Research, Advertising, Audit, Budgetary, Data Entry, Data Management, Filing, Gastroenterology, Recruting, IRB admministration, regulatory, phase ii, clinical trials, ICH-E6 GCP and GLP, HIPAA compliance
Quality Assurance Director - 11 Years of Experience - Near 07076
SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...
Tags for this Online Resume: Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development
Clinical Research - 16 Years of Experience - Near 07052
SUMMARY: Clinical research professional with experience conducting and managing sponsor related clinical trials Phases I-IV following GCP and ICH requirements and guidelines. Clinical trial experience in various indications including Oncology (Solid Tumors, Prostate, Lymphoma and Renal Cell Carcinoma) and Cardiovascular (myocardial infarction, acute ischemic stroke, and Venous Thrombo-Embolism). Strong team player experienc...
Tags for this Online Resume: Management, Billing, Direct Patient Care, Integrate, Inventory, Inventory management, Medical, Medical Billing
Clinical Research
SUMMARY Accomplished individual with strong background in understanding complex relationships between critical organizational elements well enough to unlock great organizational performance. Outstanding communication with proven ability to build and lead highly efficient teams, to train technical personnel and to convey complex concepts in understandable terms. Skilled in multiple areas of technology, including advanced Mic...
Tags for this Online Resume: Quick Books, Quickbooks, Accounting, Accounting Functions, ATX (Network Provider), Customer Relationship Management, Microsoft Access, Software, Software Development, Accounting Software, clinical, protocol, ich, trial, gcp, phase, pharmaceutical
Certified Clinical Research Coordinator - 13 Years of Experience - Near 34202
Seasoned Certified Clinical Research Coordinator with 13 years' experience as a CRC, including experience in marketing, advertising, and regulatory document completion and submission. Completed my duties with great attention to detail, compassion, professionalism, confidentiality, and care. Seeking a position in healthcare/clinical research/pharmaceutical industry that will allow me to continue to exercise these skills and ...
Tags for this Online Resume: Clinical Research, Research, Good Clinical Practices, Protocol, Advertising, Documentation, Marketing Management, NPI, Training, Accounts Payable, clinical, trial, phase, gcp, protocol, pharmaceutical, GCP, IRB, CRF, ich, AE, SAE, SUSAR, Inclusion and Exclusion Criteria, ECG, Biological, PK, PG, Substudy, ICF, EDC, Rater, concomitant medications, IP, IP accountability, regulatory documents, master file
