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Online Resumes with "edc"
Clinical Quality Assurance - 10 Years of Experience - Near 27571
Career Summary As a Senior Quality Control Analyst, I am responsible for planning, auditing, developing, documenting and implementing a quality framework for processes and associated training materials for Interactive Response Technology (IRT) and Electric Data Capture (EDC) systems. I also have experience as a Quality Control/Assurance Auditor. I have performed internal and external audits for validating clinical software,...
Tags for this Online Resume: Data Management, Management, Process Improvement, SAS, Documentation, Test, Test Cases, Data Entry, Database, Database Design
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
Clinical Research - 15 Years of Experience
Tags for this Online Resume: gcp, ich, oncology, clinical, protocol, CTMS, EDC
Financial Analyst - 20 Years of Experience - Near 19403
eClinical (Division of BioClinica) (2013 - to present) A global clinical data services software provider of electronic data capture (EDC) services and a comprehensive array of broadly interoperable eClinical data solutions to the pharmaceutical and biotechnology industries
Tags for this Online Resume: Financial, General Ledger, MRP, Accounting, Accounts Payable, Acquisitions, Cost Accounting, Database, Due Diligence, Oracle
Quality Assurance Specialist - 10 Years of Experience - Near 77071
SUMMARY: * Testing experience in a Lean-Agile Scrum (sAFE) Environment and Waterfall Environment. * Dynamic, skilled professional with Ten years of proven track record of producing high quality deliverables in mission critical projects for the client. * Dealing with multiple streams of projects and offshore/Nearshore teams as QA Lead. Also, communicated with Offshore/Nearshore teams to coordinate/sync the progress of the te...
Tags for this Online Resume: Quality, Apple Mac OS X, Apple MacIntosh Operating System, Applications, Integrate, Mac OS X, Management, Microsoft Access, Automation, Microsoft SQL Server, sql, java, c++, agile
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
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
Accomplishments: * Compliance- Maintained compliance with regulatory standards. Ensuring site staff was trained and followed all guidelines set forth by the FDA. * Implementation-Implemented a new tracking system that resulted in improved query resolution. * Documentation-Ensured study sites followed ALCOA to ensure accuracy of through precise documentation. * Patient Safety-Ensured quality control through following ICH/GCP...
Tags for this Online Resume: Audit, Compliance, Data Quality, Documentation, Forth Programing Language, Good Clinical Practices, ICH, Management, Monitoring, Protocol
Developer
Summary * Total experience of 6.5 years as Senior Software Engineer worked mainly on software Design, Coding, Testing and Integration. * Experience in Automotive Embedded Systems (CAN Communication, Diagnostics ( I14229, I14230, OBD II I15031), Engine Control Unit and Den ox Control Unit Software's). * Requirement Analysis and Documentation using XMETAL/ASCET. * Involved in Software Development of DENOX, ECU and Diagnostics...
Tags for this Online Resume: Android, Applications, Clearcase, CMMI, Data General Eclipse, Diagnostics, Eclipse, Eclipse IDE, Electronics, HTTPs
Financial Analyst - 25 Years of Experience
To secure a position within your establishment where I can exercise my experiences in Financial Analyses, Business, Budgeting & Financial Planning, Variance Reporting, Investment & General Accounting practices. Currently Self Employed as a Financial and Business Consultant January 2013 to Current Setting up new businesses. Overseeing their initial operations and start up. Securing Business Loans for new business. Building t...
Tags for this Online Resume: Accounting, Banking Industry, Financial, IBM, Its, Lotus, Lotus 1-2-3, Management, Microsoft, Microsoft Office, accounting, finance, excel, accountant, controller
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
Case Manager - 20 Years of Experience - Near 21224
SUMMARY: 30 years Clinical Research and home-based monitoring experience 12 years Oncology monitoring experience 12 years Pediatric Nurse experience Largest workload: 5 - 6 protocols with 10-15 sites in Oncology-Non-Small Cell Lung-Phase III, Neurology-Multiple Sclerosis-Phase III while at EMD Serono 10 years experience with Inform EDC and 6 months experience with IMedidata Located 20 minutes from Baltimore Washington Inter...
Tags for this Online Resume: PEDIATRIC, Clinical Research, Research, Management, Therapy, Oncology, Protocol, Audit, Monitoring, Critical Care - Neurology, registered nurse
