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Online Resumes with "Clinical Study Reports"
Clinical Research - 1 Years of Experience - Near 35806
Professional Summary: Dynamic Clinical Research Scientist with five years of international research experience. Demonstrated expertise performing research feasibility, data collection and analysis, investigative procedures verification and report preparation. Proven medical knowledge of cardiology, nephrology, emergency medicine, intensive care, endocrinology, and gastroenterology. Skilled at researching diabetes and metabo...
Tags for this Online Resume: Clinical Research • Data Management • Statistics • Drug Safety • Clinical Study Reports • Diabetics Interventions Budget Management • Clinical Operations • Regulatory Submission Documents • Protocol Preparation • QA / QC Clinical Study R, GCP, FDA, TPD Regulations FDA Regulations • Clinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutical, gcp
Clinical Research - 10 Years of Experience - Near 18901
Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...
Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development
Physician
Profile Experienced, highly motivated healthcare professional with notable accomplishments in clinical and basic research achieved in both academic and pharmaceutical industry arenas. Broad knowledge of all aspects of therapeutic product development. Extensive experience in strategizing and implementing global clinical research and development programs. Known for particular expertise and success in early clinical developmen...
Tags for this Online Resume: Clinical Research, Research, Cardiovascular, Endocrinology/Metabolism and Internal Medicine, Patient Care, Clinical Pharmacology, Protocol design/ Medical Monitoring, Budget Review, Budgeting, Board Certified/ Internal Medicine, Subspecialty-Endocrinology/Metabolism, Pharma/Clinical Research - Phase 1,2,3, Pennsylvania/ Pfizer (formerly Wyeth), Phase 1 and 2
Director
QUALIFICATIONS: Over twenty years drug development experience ranging from pre-clinical pharmacology / toxicology to managing and directing clinical and cross functional teams in the conduct and execution of global, clinical trials. Experience includes coordinating and planning for budgeting, resourcing, drug supply, site and sponsor audits, and global regulatory submissions. Management experience includes management of in-...
Tags for this Online Resume: Data Management, Management, Nephrology, Clinical Research, Clinical Study Reports, Drafting, Oncology, Project Management, Project Manager, Protocol
Contract Medical Writer - 10 Years of Experience
Biomedical Ph.D. from Duke University with almost 10 years of diverse medical writing (regulatory and publications) and pharmaceutical industry experience supporting multiple phase I, II, and III trials. Seeking contract medical writing roles in a pharma/biotech setting.
Tags for this Online Resume: Clinical Study Reports, Medical Writer, Pharmaceutical, clinical trial, CTD/NDA, protocol, regulatory, publications
Biostatatician - 4 Years of Experience - Near 15217
SUMMARY OF QUALIFICATIONS * Four years of experience performing analyses for clients to help in grant submissions, publication of peer-reviewed manuscripts, and abstracts * Expertise in the analysis of high dimensional data * Proficient with statistical software SAS and R * Excellent oral and written communication skills * Apply a wide range of statistical methodology to analyze data from wide variety of fields as a consult...
Tags for this Online Resume: Clinical Study Reports, Communication Skills, Data Analysis, SAS, ICH, Microsoft, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Presentation Skills, R, Philadelphia, high dimensional, consulting
Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440
Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...
Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality
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
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
Analytical Chemist
● Utilizes broad technical knowledge and troubleshooting skills to perform testing of a various biological matrices ● Utilizes Labnotes, Watson for transferring the samples and data ● Experiences in current Good Manufacturing Practice (cGMP), current Good Laboratory Practice (cGLP), Standard Operating Procedures (SOPs), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), requirements and Health Author...
Ideal Companies: Pharmaceutical
Tags for this Online Resume: Manufacturing, High Performance Liquid Chromatography (HPLC), Teamwork, Troubleshooting, Research, Instrumentation, Chemistry, HYGIENE, Millenium (Sw-Fin/Admin), Millennium
Licensed Nurse - 20 Years of Experience - Near 18974
I have extensive experience in writing clinical and regulatory documents in the Pharmaceutical industry which include regulatory and safety I have completed medical encoding (MeDRA), data and quality review management. My past experience included responsibilities for preparing safety sections within key documents such as Investigations Brochure, clinical study reports, writing safety narratives to be included in final stud...
Tags for this Online Resume: Management, Oncology, DS, Query, Medical, Oracle, Oracle Clinical, Database, Encoder, Risk Management
