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Online Resumes with "GCP "
Clinical Data Management
To utilize my knowledge, skills and attitude towards growth & try my level best to reach the hallmark of the organization, which would continuously challenge my interpersonal, communication and organizational skills
Tags for this Online Resume: Management, Protocol, Data Management, Distribution, Quality, Quality Assurance, Quality Control, Query, SAS, Script, oncology, pharmaceutical, protocol, OC-RDC, InForm, ICH GCP
Clinical Research - 4 Years of Experience - Vancouver, B.C
HIGHLIGHTS OF QUALIFICATIONS * Over 4+ years of progressive work experience in clinical and academic research hospital settings, collaborating with investigators and a multidisciplinary health care team in the recruitment of study participants for various investigator-initiated and industry sponsored clinical trial studies. * Strong working knowledge of guidelines and policy governing clinical research and applicable regula...
Tags for this Online Resume: Protocol, Collection, COPD, Pulmonary, Scheduling, Specimen Collection, Amazon Elastic MapReduce, Applications, Assessments, Attention to Detail, cro, pharmaceutical, clinical trials, research, clinical, regulatory, phase i, phase ii, phase iii, phase iv
Clinical Data Management - 2 Years of Experience - Near 08502
Tags for this Online Resume: Direct Patient Care, Oncology, Patient Care, Medical, Behavioral Health, Cardiopulmonary resuscitation (CPR), ELISA, First Aid, Medical Records, Microsoft, gcp, pharmaceutical, oncology, ER
Clinical Research - 12 Years of Experience - Near 07086
EXPERIENCE Summary Write and review protocols that are in-line with the indication strategy. Conduct medical review and interpretation of efficacy and safety data from clinical trials. Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, review of Investigator Brochures, CTAs, Safety Data, Clinical Trial reports. Review and provide US feedback to protocols. Work with Clinica...
Tags for this Online Resume: Biopsy, Data Management, Management, Research, Chemotherapy, Clinical Research, Drafting, Process Improvement, Program Manager, Radiation
Biochemist - 10 Years of Experience - Near 01760
Tags for this Online Resume: trial, gcp, oncology, protocol
Clinical Regulatory Affairs - 2 Years of Experience - Near 02215
PROFESSIONAL SUMMARY: A Regulatory Project Manager with 2+ years of managing IND/NDA/BLA review processes and 1+ years of cGMPs experience in pharmaceutical industry. Deadline-driven and highly reliable professional, successfully managing over 300 applicants' submissions in IND, NDA, BLA, and BSE as well as participating in 4 cGMPs sponsors' inspections (Japan and Taiwan) and 1 FDA inspection at manufacturing plants. Great ...
Tags for this Online Resume: Compliance, Pharmaceutical, Project Management, Regulatory affairs, CMC, NDA, IND, BLA, cGMP, GCP, ICH
Clinical Research - 10 Years of Experience - Near 30067
SUMMARY OF EXPERIENCE: Ensuring quality and integrity in the conduct of clinical research studies to comply with standard operational procedures as defined by GCP and FDA regulations. Manage the conduct of clinical trials within the United States and International markets. Responsible for the delivery of high quality data considering resources, time and cost. Therapeutic areas include: * ONCOLOGY * INFECTIOUS DISEASE * CNS ...
Tags for this Online Resume: Clinical Research, Research, Pharmaceutical, phase i, phase iv, phase ii, phase iii, pharmaceutical, regulatory, cro, clinical trials, research, clinical
Document Specialist eTMF
-Professional Summary- Fourteen years of experience working with Contract Research Organizations (CROs), expertly gathering and analyzing data for highly confidential clinical trials. Excellent knowledge in clinical research regulatory requirements, study protocols, FDA, good Clinical Practices, 21 CRF Part 11, HIPPA, CDISC, ICH guidelines and Standard Operating Procedures. Proficient skills in Electronic Data Capture (EDC)...
Tags for this Online Resume: Management, Quality, Quality Assurance, Quality Control, Test, Coding, Query, oncology, clinical, pharmaceutical, protocol, gcp, trial, phase, ich
Physician Assistant - 16 Years of Experience - Near 01760
Summary of Qualifications Proficient in GCP, ICH and federal regulations and guidances Independently managed all aspects of clinical trial coordination from pre-initiation to close-out Consistently met extremely tight timelines through strong organizational skills and ability to prioritize Identified as key thought leader by pharmaceutical companies and other healthcare professionals Creative thinker and problem solver, det...
Tags for this Online Resume: Clinical Research, physician assistant, outpatient, Patient Education, 16 years of experience, Boston Metrowest Area
Clinical Research - 1 Years of Experience - Near M1W 2T1
Foreign-trained medical doctor and clinical research professional with CRA Professional Development Clinical Site Monitoring & ICH GCP Training. Experienced in clinical study files review to ensure accuracy of all the documented data including ME & AEs. Comprehensive knowledge of clinical research methodology and proficient in Phase I-IV clinical studies and ICF processing and study protocols. Excellent time management and ...
Tags for this Online Resume: Toronto, Canada, Strong Clinical Trials & Medical Management background, Detail Oriented, Data Review, Clinical Trials Supervision, Team player, Quick Learner, Certified CR Professional with Medical Background, Compliance, Documentation, clinical, research, phase i, phase ii, clinical trials, phase iv, pharmaceutical, cro
Laboratory Manager - 18 Years of Experience - Near 28037
Qualifications Summary Laboratory Manager with extensive experience in regulated pharmaceutical manufacturing and research and development with more than 10 years of management experience. Thorough understanding of regulated Laboratory environments including but not limited to GMP, GLP, GDP and 21 CFR Part 11. Quick learner with proven track record of driving success. Skilled at navigating FDA and vendor audits. Implemented...
Tags for this Online Resume: Project Leader, Project Management, Budgetary, Drafting, High Performance Liquid Chromatography (HPLC), Management, Planning, Rational, White Papers, clinical, phase, trial, gcp, protocol, pharmaceutical, Quality, LC/MS
Life Scientist - 20 Years of Experience - Near 02642
SUMMARY IT/QA PROFESSIONAL Biotech - Pharmaceutical - Medical Device - Life Sciences Highly skilled consultant and Project Manager with diversified domestic and international experience and a background that incorporates strong technical orientation with business skills. Hold proven record of success in product development, process improvement, cGMP compliance, validation and quality control. Examples: * Software Implementa...
Tags for this Online Resume: Software, Compliance, HVAC, Management, Support, Assessments, Automation, Integrate, Manufacturing, Millenium (Sw-Fin/Admin), gcp, pharmaceutical, sas, protocol, clinical
