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Online Resumes with "Study Reports"
Clinical Research - 5 Years of Experience
Medical Doctor with Post Graduate training and Diploma in Clinical Research from AAPS Toronto * Over 14 years experience working in clinical environment. * Strong understanding of Clinical Research processes according to Study Protocols ICH/GCP
Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Data Management, Good Clinical Practices, Medical, Clinical Trials, Informed Consent Forms, Study Reports, SOP, Regulatory approval
Electronics Engineer - 20 Years of Experience - Near 76022
An Electronic Project/System/Test Engineer with extensive experience in all facets of engineering experience. Strong background in project/program management, testing, and development with a commitment in meeting the overall strategic goals of the company and customer. Able to quickly establish rapport with both customers and team members. Proven ability to demonstrate well-developed analytical, problem-solving, and deci...
Tags for this Online Resume: Avionics, Budgeting, Data Management, Engineering, Failure Analysis, Inventory, Management, Support, project engineer, project manager, Electronic System, IVV, First Article & Qualification Testing/Inspection, ISO, Test Procedures, Technical & Test Reports, Component Engineering
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
Mechanical Engineer - Near 77072
SUMMARY: * 25 years of experience in Mechanical & Piping Field/Construction/Design Engineering, Project Engineering, Oil & Gas, Process, Power Utility Systems/Maintenance Engineering * Managed various Mechanical Utility Systems, Supervision and Design/Construction in Mechanical components & piping systems for Various DOE/Commercial Projects. * Responsibilities have included working closely with clients, management, and in a...
Tags for this Online Resume: Test, Test Plans, NCR, Test Plan, Quality, Valves, Management, Project Management, Utilities, Consulting
Instructional Coordinator - 15 Years of Experience - Near 21122
Profile Dr. Anderson has a doctoral degree in education and 15 years of experience in instructional systems design (ISD), learning technologies and adult learning. Her program management skills have maximized training potential and established highly effective learning solutions in corporate and academic training needs. Dr. Anderson has supervised complex teams comprised of SMEs, technical staff, curriculum staff and contra...
Tags for this Online Resume: Information Technology, Leadership, Management, Training, Applications, instructional designer, education, training, teaching, distance education, online learning, instructional technology
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
Medical Office Manager - 15 Years of Experience - Near 20613
Career Summary: Director of Operations - Unified Physician Management November 2015 - present Financial Payment of corporation bills before their due date. Review of bills for accuracy. Trend payment amounts and identifies problem areas. Prepare proposed annual budget. Approve all expenditures. Prepare a review and analysis of monthly statements, all special financial studies, reports, etc., as requested or deemed necessary...
Tags for this Online Resume: Billing, Deposits, Payroll, Pediatrics, Accounting, Accounts Payable, Advertising, Audit, Audit Policy, Bank Deposits
validation/quality/manufacturing engineer
PROFESSIONAL SUMMARY: * Experienced as validation engineer and experience in Process Validation, and Test Method Validation in compliance with FDA standards * Expertise in writing Test method Validation Protocols (TMV-P) and executing the protocols * Experienced in validating different types of test methods (Attribute Test Method, Variable Destructive Test Method, Variable Non-Destructive Test Method, Analytical Test Method...
Tags for this Online Resume: Reviews, Root Cause Analysis, Test, Assessments, Documentation, PFMEA, R&R Report Writer, Regulatory Affairs, Reliability, Risk Assessment, manufacturing
Project Manager
Summary Lifetime technology Enthusiast utilizing cloud computing, Salesforce CRM, Scrum for continuous improvement (kaizen). o Certified Scrum Master / Program Manager: Leading cross-functional teams to execute C-suite's vision. o Consulting subject matter experts, creating requirement study reports, and defining project sprints and deliverables. o Coordinating external vendors and consultants towards project progress. o Us...
Ideal Companies: Amazon, Facebook, Salesforce
Tags for this Online Resume: Change Management, Communications, Construction, Content Management, Customer Relationship Management, Government, Internal Communications, Light Emitting Diode, Management, Microsoft Change Management
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
Civil Engineer - 20 Years of Experience - Near 21045
SUMMARY Results-oriented Engineering Senior Project Manager and Project Civil Engineer with experience in the successful management of wastewater and water infrastructure projects. Presently preforming duties as Assistant Department Manager and Departmental QA/QC Manager. Planned, designed and constructed sewage collection systems, pump stations, water transmission systems and other capital improvement projects. Overseen de...
Tags for this Online Resume: Budgeting, Certificate Authority, Civil Engineering, Collection, Compliance, Construction, Engineering, Geographic Information System, Infrastructure, Leadership, mechanical engineering, project manager, project engineer
