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Online Resumes with " GCP"
Senior Business Systems Analyst/IT Project Manager - 7+ Years of Experience - Chicago IL
Strategic and innovative Senior Business Systems Analyst/IT Project Manager with over 7+ years� experience leading large scale IT projects. Highly accomplished and forward-thinking, with diverse expertise in IT systems and business systems analysis. Talented senior system analyst and senior business systems analyst with broad IT experience across multiple sectors. Create, design and implement efficient, consistent and strea...
Ideal Companies: Baxter, Takeda, JP Morgan Chase, Citibank, HSBC, Allstate, Bank of America, Standard Chartered, State Farm, Johnson & Johnson, Procter & Gamble
Tags for this Online Resume: Business Requirements to System Design, Laboratory/QA Systems like LIMS, Empower 3, ELN, Atlas, SDMS NuGenesis Configuration/testing, Regulatory Compliance for FDA, EU Annex 11, 21CFR Part11 Compliance, ERP SAP-QM, SDLC/Waterfall/Agile Development Methodologies, Project Management, Custom Software Development, Systems Engineering, System Risk Mitigations/Integrations, Enterprise wide implementation, ROI Analysis, Costing , UAT, System Integration Testing, Performance Testing, Regression testing, Acceptance Testing, Validation Testing Scripting and documentation. GXP, GMP, GLP, GCP, Lean Six Sigma Green Belt expertise, C, Oracle 10g/11g, SQL Server, PL/SQL Stored Procedures, Costing, Project Scheduling, Cross-Functional Supervision, Team Building, Client Relations Presentations, Business/IT Planning, Vendor Management, UML Designing, MS Project, Gantt Chart, MS Office, Rational Rose, URS, FRS, SDD, Installation, Traceability Matrix, BI, Cognos, QlikView, Infomaker Report, MS Test Manager, Sharepoint, Business Operation Excellence, Process Improvement Excellence
Clinical Regulatory Affairs - 20 Years of Experience - Near 92694
I love what I do. Although, I have a broad knowledge of Clinical Trials and the desimenation of these trials/studies I love being a part of from first launch to final result. To continue in a job that enables all of my capabilities and to manage/direct the dynamic teams it takes to complete this effort is of great reward and love helping and giving back to our patients we represent.
Ideal Companies: Pharmaceutical companies
Tags for this Online Resume: manager, director, clinical trials, GCLP, ICH, Liaison, Client, Clinical, Site Manager, global, audits
Biological Technician - 4 Years of Experience - Near 33549
Summary 10 years of managerial experience and training development. An unremitting individual determine to accomplish achievement through hard work. "https://www.employflorida.com/vosnet/ind/indemphistory.aspx*resid=218383&session=resbldr" Employment History "https://www.employflorida.com/vosnet/ind/indemphistory.aspx*resid=218383&session=resbldr" 3/2/15 - Current Laboratory Lead Technical Support Specialist Clearwater, FL ...
Tags for this Online Resume: Retail, Sales, Sales Training, Support, Technical Support, Training, Accounting, Inventory
Clinical Research Associate - Entry level - Waterloo
Driven, dynamic, and detail oriented. Trained in ICH/GCP guidelines to monitor clinical trial processes. Actively seeking an entry level CRA position within clinical trial programs.
Tags for this Online Resume: ICH/GCP, Clinical Research, SOPs, Case Report Forms, Microsoft Office Suite, Phases I - IV trials, Recruitment
Medical or Health Services Manager - 10 Years of Experience
Summary * 10 years of work experience in Clinical Data Management * Currently serving as Data Team Lead in global studies and also as an Associate Manager in Clinical Data Management. * Possess the ability to adapt to any situation and work well with others through effective communication and interpersonal skills Experienced with data management tools processes and therapeutic areas * Responsible for leading the DM team and...
Tags for this Online Resume: Support, Team Lead, Business Development, Data Management, Financial, Financial Management, Management, Pricing
Clinical Research - 7 Years of Experience - Near 40009
Tags for this Online Resume: Source data verification, ICH GCP, Site monitoring, CRF review, Communication with site, Ethics committee and sponsor, compliance to protocol
Biostatatician
SUMMARY Accomplished and result-driven Quality and Regulatory Affairs professional with 15 years of experience in the Medical device and Drug industry, along with over 17 years of leadership, project management and process improvement (Six Sigma or lean manufacturing). ACCOMPLISHMENTS * Developed, implemented and managed quality systems in GMP and GCP settings based on FDA, ISO, MDD, CMDR, ICH, and IEC regulations and guida...
Tags for this Online Resume: Training, Cardiovascular, CT, Documentation, Imaging, Magnetic Resonance Imaging (MRI), Management, Medical
RN Medical Coder - 18 years experience
Remote Medical Coder experienced in with ICD-9CM, ICD-10, WHODrug, WHO-ART, COSTART and MedDRA coding practices. Knowledge of diseases, drugs, dictionaries, and coding conventions. Multiple compound ownership interfacing with Clinical, Clinical Data Management and Clinical Safety to ensure appropriate coding for report analysis. Responsibilities include the daily running of studies, documentation of all procedures, regular...
Clinical Pharmacovigilance/Drug Safety - 2 Years of Experience - Near 27713
Tags for this Online Resume: FDAguidelines, Medical writer, ICH GCP, Essential documents, Regulatory guidelines, E3 guidelines, Investigator brochure, ICF
Biostatatician - 5 Years of Experience
Profile A multilingual result-driven biostatistician and SAS programmer with more than 15 years of professional experience. Broad experience of data manipulation in medical research, pharmaceutical research, clinical trials. Thorough knowledge of drug development processes at CROs, ICH guideline and GCP certificate. Proficient at SAS programming with 8 years of experience in data analysis, statistical modeling, data prepara...
Tags for this Online Resume: Active Directory Application Mode (ADAM), Data Analysis, Medical, Statistical Analysis, Programming, Protocol, Research, SAP
Physician - 19 Years of Experience
Transitioning from direct patient care to a research-based career. Looking for Clinical research associate (CRA) openings.
Tags for this Online Resume: Medically trained., Clinical Research, SOP, GCP, ICH
Medical Office Manager - 1 Years of Experience - Near 02120
Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...
Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device
