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Online Resumes with "ICH "



Senior Clinical Research Associate-7 years of experince

I am an ambitious person, a hard worker with full determination and dedication who likes to succeed in an environment of growth and excellence. I always seek continuous learning to keep myself dynamic, visionary and competitive with the changing scenario of the world.

Tags for this Online Resume: clinical research, ICH-GCP, Site monitoring activity, clinical trial activity experience, different therapeutic phases, site management skills

Clinical Quality Assurance - 20 Years of Experience - Near 19713

AREAS OF EXPERTISE * Quality Assurance, CAPA * Regulatory Stability Documentation * Quality Systems * Strategic Project & Team Management * Troubleshooting / Problem Solving * Stability protocols, SOP's * USP, BP EUP, JP * FDA and ICH guidelines * Chromatographic Data Systems * Method validation and metrics * Lab Inspections & Evaluations * Product Support / Quality Control * Standard Operating Procedures

Tags for this Online Resume: Stability, Quality Assurance, Data Management, Quality Control, Data Analysis, LIMS, Reference Standard, COA Management, FDA and ICH Guidelines, USP,EUP,BP,JP, HPLC, GC etc., pharmaceutical, protocol, ich

Clinical Regional Monitoring - 3 Years of Experience - Near 0000

PROFESSIONAL SUMMARY Clinical Research Professional with various project experience from concept to development. Talents include in-depth knowledge of ICH guidelines SAE reporting and GCP auditing. Integral team-player with excellent communication skills CORE QUALIFICATIONS * Patient Recruitment & Screening * Detailed Documentation * Serious Adverse Event Reporting * Communicating with IRB for study proposal, approval and u...

Tags for this Online Resume: Clinical Research, Data Entry, Research, Audit, Communication Skills, Compliance, Documentation, Excellent Communication Skills, Good Clinical Practices, ICH

Clinical Data Management - 5 Years of Experience - Near 56003

SUMMARY * 5.4 years of experience in analyzing and gathering data for Clinical trials. * Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the data-management lifecycle. * Work closely with Oracle Clinical developers on the design, testing and implementation of study databases. * Extensive experience in trial start-up, trial conduct, database lock and Post data...

Tags for this Online Resume: Data Entry, Management, Protocol, Cancer, Immunology, Infectious Diseases, Query, Team Lead, Data Management, Data Manager, oncology, phase, clinical, trial, protocol, gcp, pharmaceutical, ich, OC database, OC-RDC-TAO database

Medical Scientist - 10 Years of Experience - Near 28409

Tags for this Online Resume: oncology, protocol, pharmaceutical, phase, trial, gcp, clinical, ich

Clinical Research - 14 Years of Experience - Near 27523

Objective: Lead clinical/project teams, continuing to manage and mentor clinical research experts, using skills, experience, and wisdoms to increase operational effectiveness. • Experienced in mentoring junior CRAs and project team members, training large or small groups in various areas of the clinical trial process, creating executive and operational reports, managing project timelines, and monitoring clinical sites sho...

Tags for this Online Resume: Management, Project Management, Support, Training, Process Improvements, Customer Service, Clinical Research, Medical, Monitoring, Research, Analysis, Critical Thinking, clinical, trial, gcp, protocol, pharmaceutical, ich, phase, Mentor, Team Lead, phase iv, phase ii, phase i, research, phase iii, clinical trials, regulatory, cro

Clinical Data Management - 4 Years of Experience - Near 05000

Tags for this Online Resume: Data Manager, Information Technology, Pharmokokinetics , Data Management, Management, Reliability, ADO.NET, Clinical trial, Audit, Bilingual, clinical, trial, protocol, pharmaceutical, gcp, phase, ich, data science, programmer, educator

Clinical Project Manager- 20 Years of Experience - All Phases of Development

Tags for this Online Resume: Management, Leadership, Project Management, Compliance, Documentation, Planning, Strategic Planning, Pharmaceutical, Billing, phase, trial, gcp, protocol, sap, ich, sas, oncology, Clinical Neuroscience, clinical, pharmaceutical

Director / Manager Quality Assurance

Apply my skill sets to promote regulatory compliance of your research business!

Tags for this Online Resume: Compliance, Quality Assurance, Scheduling, Test, Toxicology, Management, Audit, Corrective Actions, Due Diligence, protocol, pharmaceutical, ich, gcp, phase, GLP, Bioanalytical

Regional Home-Based CRA

Tags for this Online Resume: oncology, phase, clinical, trial, gcp, protocol, pharmaceutical, Cardiovascular, CRO, Neurology, Bone, immunotherapy, monitoring, Initiation, close-out, Remote, query, onsite, SOP, ICH, GCP, investigator, IRB, sponsor, CTMS, CNS, Endocrinology, Haematology, ICF, Informed Consent, EDC, SDV, InFORM, MediData Rave, eTrial, eDiary, MedWatch, Adverse Event AE, SAE, 1572 Statement of Investigator, IB, Trip Report

Clinical Regional Monitoring - 19 Years of Experience - Near 07981

Areas of expertise: Anti-infective Cardiac, Gastro, Oncology, Hepatitis C, RA, MS, Graft vs Host Disease, Oncology Study phase experience: Predominantly Phase I (Start up through CSR), II, and III. Some experience in phase IV (mostly in the SAE arena).

Tags for this Online Resume: Hepatitis, Hepatitis C, Training, Project Management, oncology, phase, clinical, trial, gcp, protocol, pharmaceutical, ich, Regional, Contract, Remote, management

Clinical Research - 7 Years of Experience - Near 37208

Summary of Qualifications Detail-oriented, enthusiastic, and highly motivated Research Professional with 19+ years of successful experience. Diverse background encompasses research, laboratory analysis, reporting, and project/study planning and execution experience. Skilled at ensuring compliance with Standard Operating Procedures (SOP), Good Clinical Practices (GCP), and applicable policies and regulations. In-depth knowle...

Tags for this Online Resume: Instrumentation, Research, Quality, Quality Assurance, Quality Control, ISO, Toxicology, Leadership, Automation, Chemistry