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Online Resumes with "GCP "
Clinical Research
PROFESSIONAL SUMMARY Persistent, Organized and detailed oriented professional interested to pursue a position as a Clinical Research Associate (CRA) with a pharmaceutical / biotechnology firm where I can utilize my medical and clinical research knowledge along with my strong technical and procedural skills in clinical monitoring to meet the growing needs for clinical trials of new drugs in multiple therapeutic areas. CORE Q...
Tags for this Online Resume: Protocol, Clinical Research, Research, Complaints, Documentation, Interactive Voice Response, MDR, Voice
Lead Clinical Research Coordinator - 4+ Years of Experience - Near 48304
Tags for this Online Resume: SPSS, CCRP, IRB documents, Multicenter Clinical Trials, SAE reporting, Data management, internal monitoring, GCP and FDA regulations
Documentation
Seek challenging opportunity. My work experience and qualifications are diverse and include 10 years contracting to the Pharmaceutical Industry. Recently, I’ve earned applicable Clinical Trial subject matter certificates e.g., Kriger Research Group International (KRGI): Clinical Research Professional ICH/GCP – Certificate 9/2009; KRGI: Medical Terminology Program – Diploma 1/2010; Allied Schools: Pharmacy Technician Progra...
Tags for this Online Resume: Documentation
Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021
Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...
Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India
Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment
Clinical Quality Assurance - 17 Years of Experience - Near 27713
QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...
Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance
Clinical Research - 6 Years of Experience - Near 20877
Skilled Clinical Professional with experience in Site Management ensuring that the conduct of the trial is in compliance. Provides effective leadership and teamwork by coordinating and integrating services within the clinical environment. Experience with remote monitoring of multiple site locations clinical site initiation and maintenance in accordance with GCP and company SOPS's while ensuring integrity of study data and f...
Tags for this Online Resume: Insurance, Management, Billing, Computerized scheduling, General Practice, Microsoft, Microsoft Excel, Microsoft Outlook
Clinical Research
Experienced Clinical Research Associate seeking a challenging and rewarding Clinical Research Associate (CRA) position that will utilize my clinical site monitoring and general management skills and experience to coordinate, monitor and manage all aspects of clinical trials in accordance with the ICH-GCP guidelines, FDA regulations, standard operating procedures and study protocol.
Clinical Research
SUMMARY: * POST-MARKETING REPORTING: Vast clinical experience in reporting post-marketing events in the pharmaceutical industry. * CDM: Acquaintance on clinical data management, pre-clinical and clinical trials (Phase I, II, III and IV) * CLINICAL WRITING & DOCUMENTATION: Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard...
Tags for this Online Resume: Ipc, Planning, Protocol, Research, Reuters, Business Planning, Coding, Documentation, Immunology, Information Technology
Clinical Research - 6 Years of Experience - Near 75287
PROFESSIONAL SUMMARY: A CRA with strong eye for detail and exceptional ability to interpret and follow instructions Possesses the ability to collect accurate data in line with client specifications excellent analytical and organizational skills knowledgeable in FDA regulations, GCP/ICH guidelines, seeking to join an organization that makes research subjects' safety its first priority. CORE QUALIFICATIONS: * Over 5 years exp...
Tags for this Online Resume: Management, Clinical Research, Data Management, Protocol, Research, Assessments, Forth Programing Language, Good Clinical Practices, Monitoring, Training
Clinical SAS Programming - 20 Years of Experience - Near 78681
SUMMARY: A Senior Programmer with 23 solid years of SAS clinical research experience including SAS/MACRO, SAS/STAT, SAS/GRAPH. Highly proficient at producing Tables, Listings, Graphs and ISS/ISE Reports. Knowledgeable of all aspects and Phases of Clinical Trials. I have worked with many pharmaceutical companies including Amgen, Lilly, Pfizer, Allergan, P&G, Novartis, Schering Plough, BMS, Merck, McNeil and Shire. I'm also p...
Tags for this Online Resume: SAS, Data Management, Management, Programming, Quality Assurance, Test, Project Management, Documentation
Clinical Research - 15 Years of Experience
Focused on obtaining a position as a Clinical Research Associate. Detail oriented with the ability to plan organize coordinate and manage projects according to priorities. Ongoing and consistent promotion of team work efforts. Excellent Communication and Interpersonal skills. Excellent oral and written communication skills with the ability to communicate effectively with medical personnel. Quick learner with the ability to ...
Tags for this Online Resume: Documentation, Management, Cardiovascular, Cardiology, Clinical Research, Distribution, Good Clinical Practices, Research
Clinical Research
PROFESSIONAL SUMMARY: Licensed Pharmacist from India with Masters in Pharmacology. Over 7+ years of experience in the Pharmaceutical industry with focus in Pre-clinical and clinical trials and a strong understanding of cGMP, GCP, FDA regulation and ICH guidelines. Have an Extensive knowledge as a Quality Assurance officer and outstanding interpersonal skills with a track record of establishing positive relationships with cu...
Tags for this Online Resume: Clinical Research, Email, Management, Project Management, Project Manager, Protocol, Research, Canvas
