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Online Resumes with "ICH "
Clinical Research - 12 Years of Experience - Near 32837
Profile: Clinical Research Professional with vast experience in Phases I- IV study trials in Oncology,
Tags for this Online Resume: Protocol, Good Clinical Practices, Quality Assurance, Test, Oncology, Management, Research, Clinical Research, Data Management, Phlebotomy, clinical, phase, trial, pharmaceutical, gcp, protocol, ich
Clinical Research
To apply my knowledge of FDA Good Clinical Practice guidelines/ICH guidelines, extensive site/field Clinical Director, Site Lead Study Management, in addition to my experience with various therapeutic areas of medicine, to a position as a Clinical Research Associate. Achievement: Co-Author on Two Research Article Publications
Tags for this Online Resume: Clinical Research, Documentation, Research, Management, Monitoring, Outsourcing, Policies and Procedures, Protocol, Training, Accounting
Clinical Regional Monitoring
Accomplishments: * Compliance- Maintained compliance with regulatory standards. Ensuring site staff was trained and followed all guidelines set forth by the FDA. * Implementation-Implemented a new tracking system that resulted in improved query resolution. * Documentation-Ensured study sites followed ALCOA to ensure accuracy of through precise documentation. * Patient Safety-Ensured quality control through following ICH/GCP...
Tags for this Online Resume: Audit, Compliance, Data Quality, Documentation, Forth Programing Language, Good Clinical Practices, ICH, Management, Monitoring, Protocol
Microbiologist
A Validation Engineer with proven success working with major pharmaceutical companies and diversified experience across all aspects of the industry: Quality control manufacturing regulatory compliance and multiple departmental operations. Consistently demonstrating a high level of experience in all aspects of the development execution and close out of commissioning/qualification programs using process design documentation p...
Tags for this Online Resume: Manufacturing, Assessments, Automation, Utilities, Microbiology, Protocol, Collection, Documentation, High Performance Liquid Chromatography (HPLC), Marketing Management
Clinical Research
PROFILE Decisive, action-oriented and results-focused professional offering more than 30 years of experience in the medical field with 23 years focused in clinical research. Thorough knowledge of Medicine. Ability to deal with the public in a professional, concerned manner and ability to convey a sense of confidence and trust to patients and work well with other health professionals. Knowledgeable of FDA, ICH and GCP guidel...
Tags for this Online Resume: ICH, EKG, Research, C Programming Language, Catalogs, Clinical Research, Hematology, Hepatitis, Hepatitis C, Scheduling
Clinical Research - 6 Years of Experience - Near 80918
Pursuing a challenging career in an organization where I can apply my talents and education in a medical/scientific-related field. Qualification Highlights Proficient use of Databases: iMedidata RAVE, RTOG, GOG, Inform, Oncore, CTSU, SWOG, Clincapture. Oversee RNs are strictly following X-Chart requirements of study protocols. Reviews Expectancy Reports of all associates in our department to ensure data timelines are met. R...
Tags for this Online Resume: Clinical Research, Research
You shouldn't have to read my entire resume to know I'm the one!
I absolutely enjoy what I do and look forward to work every week. I know there will be challenges and problems that my team and I will have to solve. I enjoy this career because every day is different. Every study requires a different amount of care and expertise/experience. I love the organization that comes with this career. I love having my own studies and organize documents according to company SOP as well as my own way...
Ideal Companies: Any Biopharma Company (start-up, or young companies) in Phase 1 or 2 of their studies
Tags for this Online Resume: Instant Messaging, Data Analysis, Document Management, Good Clinical Practices, Good Laboratory Practices, Management, Medical, Medical Terminology, Microsoft, Microsoft Excel, Data Entry, Site Feasibility, Trial Master File Audit, Trial Master File, Routine Monitoring Visits, Bilingual, IWRS Systems, DSMB, analysis of PK data from different generations of Japanese subjects, Receiving Plasma samples and storing them in freezers, Urine collection and UA testing, Phlobotemy, ECGs, Dosing, Writing Visit Reports, Query data sheets, Resolving Queries within the SOP allotted time frame, Pippetting Fluids and shipping off with appropriate courier., CRA visit matrixes, Reporting numbers and statistics to Project Manager and Operations Manager, Reviewing Source Documents and making original source documents according to procedures in the protocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverables, Coder
Contract Medical Writer
Summary Work Experience: Strong background in medical writing and biotechnology product and services development, with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise, analytical skills, data analysis, management experience, and medical knowledge. Participate in pre-clinical, clinical, and commercial research...
Tags for this Online Resume: Business Development, Cancer, Clinical Research, Medical Writer, regulatory science, biologics, drugs, medical device
Life Scientist
Accomplishments Identified and established productive scientific collaborations served as a scientific liaison between academic institutions, and contributed to and led multiple research programs. Proven experience in developing and planning research studies, writing scientific articles for peer-reviewed publication, developing standard operating procedures (SOPs), and presenting complex/technical information to the medical...
Tags for this Online Resume: Research, Analytical Skills, C Programming Language, Cancer, Clinical Research, Computer Aided Software Engineering, ELISA, GloboMax PDx Pharmaceutical Development Expert Tools, ICH, Imaging
Clinical Data Management - 8 Years of Experience - Near 07083
SUMMARY * Senior Clinical Trial Data Manager with extensive experience in domestic and global trial data management * Deep expertise leading Phase I-IV trials, across various therapeutic areas, including Oncology, Cardiology, and Diabetes. * Adept at serving as the liaison between Sponsor and CRO/BPO. * Deep familiarity with ICH / GCP guidelines. Experienced with Medidata RAVE, and Oracle platforms, and likewise, skilled in...
Tags for this Online Resume: Clinical Research, Protocol, Research, Oncology, Audit, Management, Project Management, Data Manager, Rheumatology, Trend Analysis
Clinical Research - 0 Years of Experience
Good expertise in clinical trials and GCP ICH and FDA regulations * Ability to anticipate problems relating to projects and to develop and implement solutions Skilled with PC applications Microsoft Office Excel Outlook Oracle including patient and study databases and spreadsheets * Manage multiple projects at varying stages of completion * Effective in setting and meeting personal short- and long-term goals to complete assi...
Tags for this Online Resume: Data Analysis, ADA, Ada Programming Language, Audit, Inventory, Medical, Medical Records, Oncology, Oracle, Pathology, clinical, phase i, phase ii, clinical trials, phase iii, cro, pharmaceutical, regulatory, research
Programmer Analyst
SUMMARY * 6 years of experience as a Statistical Programmer in Clinical trials of Pharma Industry. * Expertise in SAS programming features like BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, and ODS. * Skilled in generating reports featuring various SAS procedures, like Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort, Proc Univariate, Proc Datasets, Proc Compare, Prco SGPLOT, and Proc SQL. * ...
Tags for this Online Resume: Base SAS, Macro (Predefined Code), Proc, SAS, SAS/STAT, Statistical Analysis, Structured Query Language, Data Analysis, HyperText Markup Language, Microsoft Excel
