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Online Resumes with "GCP "



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

Chemist - 8 Years of Experience - Near 08855

SUMMARY: * Over 16yrs pharmaceutical experience in Quality Control, Stability and R&D, Drug development & approval, sterile injectable pharmaceutical manufacturing, solid dosage manufacturing, aseptic techniques, and clinical packaging/ labeling for top pharmaceutical companies. * Solid background in Instrumental Analysis and GMP compliance. Expertise in hands-on use of instrumentation such ICP, GC/MS, HPLC, LC/MS, UV, and ...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Research, SEC, Securities and Exchange Commission (SEC), Support, Instrumentation, Audit, Good Laboratory Practices, Good Manufacturing Practices, oncology, phase, protocol, pharmaceutical, clinical

Quality Assurance Manager / Vendor Manager - 20 Years of Experience - Near 60060

SUMMARY: Experienced, dedicated, Quality Assurance professional and trainer who provides the knowledge and skills to assist with and drive projects as part of a team or as an individual contributor. * 20+ years of experience in pharmaceutical research, 15+ in Quality Assurance * Experience with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH), Good Laboratory Practice (GLP), Vend...

Tags for this Online Resume: Quality Assurance, Test, Clinical Research, Research, Audit, Management, Pharmaceutical Industry, Development Activities, Policies and Procedures, Vendor Management, Clinical, GCP, GLP, Training, Nonclinical research, Preclinical, Early phase clinical research

Medical & Clinical Laboratory Technician

Summary of Qualifications: Growth-minded operational professional with a collaborative and innovative approach to problem solving. A proven ability to implement and execute project timelines, objectives, management and oversight of early phase global studies. Exceptional communication and relationship building skills allow continuous success with cross-functional, internal and external partnerships and stakeholders. * Diver...

Tags for this Online Resume: Management, Monitoring, Oncology, Protocol, Quality, Quality Assurance, Assessments, Filing, Financial, Planning

Clinical Research

ACCOMPLISHMENTS * Worked with 50 different sponsor and CRO companies on various GI studies * Managed Bunion investigational study with 300 patients. * Three FDA audits without 483. * Met all recruitment targets within required study timeframe * Managed regulatory binder for studies, post start-up * In depth knowledge of Microsoft packages ( Word, Excel and power point) Experienced with Oracle, Inform, Medidata eDC programs ...

Tags for this Online Resume: Oncology, Research, Clinical Research, Microsoft PowerPoint, Microsoft Word, Oracle, Recruiting, Staffing & Recruitment, Computer Aided Software Engineering, Good Clinical Practices

Clinical Regional Monitoring - 12 Years of Experience - Near 30339

Profile A conscientious Research Associate with 30 years of diverse experience in product development, quality assurance as well as technical service and clinical research. A persistent self-starter experienced in operating and training personnel in a variety of analytical instrumentation and procedures. Successful in finding innovative solutions to a wide range of problems in a team environment or alone. inVentive Health C...

Tags for this Online Resume: Clinical Research, Research, Training, Management, Support, Technical Support, FRACTURES, Instrumentation

Clinical Quality Assurance - 20 Years of Experience - Near 84121

SUMMARY Quality professional with a MBA and solid technical experience in a laboratory environment and in a highly regulated manufacturing environment. Expertise includes leading teams, quality support through planning and production and Material Review Board (MRB) activities, validation, raw materials and finished product testing. Solid knowledge of regulatory requirements including cGMP/cGLP/cGCP/OSHA/CDC/CAP/EHS/FDA/DEA....

Tags for this Online Resume: Inventory, Inventory Control, Oracle, Pharmaceutical, Protocol, Quality, Quality Assurance, Quality Control, Scheduling, Structural Testing

Biologist - 20 Years of Experience - Near 94085

Qualifications Profile Highly analytical, methodical, and results-driven professional with extensive background in safety management and process development with focus on cell biology within biotechnological and pharmaceutical fields. Noted for successfully overseeing and completing various tasks within a fast-paced working environment while ensuring quality of work and compliance with safety standards. Skilled in performin...

Tags for this Online Resume: Applications, Communication Skills, Compliance, Data Analysis, Focus, Good Manufacturing Practices, Leadership, Management, Manufacturing, Media Preparation, pharmaceutical, gcp, protocol, clinical, trial, phase

Clinical Research - 20 Years of Experience - Near 32828

My career objective is to become a part of your Organization and to apply my experience and knowledge during the conduct of clinical trials, with emphasis on safety, efficacy in accordance to ICH-GCP, FDA and study protocol guidelines. Further, I will always strive to accomplish efficiency and savings for clients, by developing effective monitoring tools

Tags for this Online Resume: Microsoft-Office, ICH-GCP, FDA-guidelines, CTMS, EDC, RAVE, Monitoring, Clinical trials, Cardiovascular, Management, Auditing

RESEARCH ADMINISTRATION PROFESSIONAL

Dedicated Clinical Research Professional with over 10 years' progressive experience managing multiple phases of clinical research projects. Possessing advanced education, leadership, management, diplomacy and organizational leadership skills and consistently demonstrating the highest level of personal and professional standards. Seeks a varied and challenging position that will enable me to consolidate my professional exper...

Tags for this Online Resume: Oncology, Clinical Research, Diversity, Research, Consulting, Immunology, Medication Adherence, Planning, Policy Development, Strategic Planning, clinical, research, clinical trials, cro, regulatory

Clinical Project Manager

Qualifications for Clinical Trial Management Offers extensive experience managing clinical studies and developing clinically relevant products. Adapts quickly to changing priorities in fast-paced research environments. Works well independently and as a team player/leader to solve problems and ensure excellent customer service. Detail-oriented, adaptable, and organized capable of providing home - based clinical research moni...

Tags for this Online Resume: Project Management, Project Manager, Compliance, Management, Monitoring, Audit, Clinical Research, Data Management, Protocol, Research

Clinical Research - 43 Years of Experience - Near 19438

SUMMARY: * A lifetime of working in the Healthcare Industry having served as a clinician, teacher, manager and researcher in acute and chronic care environments, transitioning into pharmaceutical, medical device industries and government agencies including National Institute of Health, National Institute of Child Health and the Department of Defense: Aviation-Space-US Air Force * Respiratory Therapy, across the human lifesp...

Tags for this Online Resume: Ventilators, Critical Care - Neurology, Critical Care - Respiratory, Home Care, Monitoring, Neurology, Acute Care, Cardiology, Respiratory Therapy, Therapy