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Online Resumes with "eTMF"
Clinical Research Associate - 5+ Years of Experience
Experienced with key clinical trial systems including CTMS, EDC, IVRS and eTMF systems,Recist1.0,ECOG,statistical concept
Ideal Companies: Roche, Pharm-Olam
Tags for this Online Resume: Clinical Research, Compliance, Documentation, Research, Good Clinical Practices, Management, Oncology, Protocol, Cardiovascular, Data Management, CTMS, EDC, SAE reporting
Accounting Clerk - 20 Years of Experience - Near 01887
PROFESSIONAL SUMMARY: Efficient and reliable professional with thirty years of experience in administrative and accounting roles. Diversified skill sets include administrative support and client relations, excellent inter-personal, phone, communication and computer skills. TECHNICAL: Very experienced in the following programs: all eTMF, Microsoft Office 2016 (Access, Excel, Outlook, Power Point and Word), Microsoft (Great P...
Tags for this Online Resume: Payroll, Accounting, Billing, Reconciliations, Accounting Functions, Administrative Support, Filing, Inventory, Medical, Medical Records
Clinical Research - 8 Years of Experience - Near 60169
Professional Summary A certified professional Clinical Research with 4 years of experience in Clinical Research coordination and a year experience as Clinical Study Associate. Expertise in QC of documents, remote Monitoring and supporting the management by handling the tasks of multiple clinical research studies managing eTMF's & designing Clinical Portfolio's from Sponsor end. Expert in liaising between different departmen...
Tags for this Online Resume: Document Management, Monitoring - Remote and onsite, Clinical Research coordinator, Device trials, clinical Research, Project Management, QC and QA, Pharmacovigilance, Ethics and compliance, regulatory, Clinical study Associate, Multiple therapeutic areas experience, Phase 1-4 trials, Audits and Inspection readiness, Multiple software and application experience - Veeva VAULT , Impact , Quest , Sentinel,Tesla, EDC experience- RAVE Medidata, IRT system experience Clinpace , Endpoint
Clinical Research
Areas Of Expertise * Good Clinical Practices * QC/QA Audits * IRB Submission/Standards In-House Monitoring * TMF Subject Matter Expert * eTMF System Validation Research Site Management * Cross-Functional Collaboration * Clinical Operations
Tags for this Online Resume: TMF, eTMF, CCRP, Site Management, Informed Consent, GCP, Document Management, IRB, Clinical Operations, Regulatory, Contracts, Budget
Project Manager
SUMMARY Experienced IT Software professional specialized in working with clients to understand and implement requirements and applications/systems to provide business analytics and strategic solutions in various roles as a Senior Business Analyst, Senior Project Manager, Senior SFDC Architect, Senior Program Manager/Product Manager and Senior Product Owner. Collaborate with product management, engineering and other cross-fu...
Ideal Companies: program mgnt
Tags for this Online Resume: Inventory, Support, Active Server Pages, Forecast, Forecasting, Oracle, Quality, Quality Assurance, Data Entry, Planning
Clinical Research - 1 Years of Experience - Near 07011
As Clinical Trails Associate and e-TMF expert, I have a solid expertise in the New Drug development process as well as a strong document management skills and experience with essential regulatory documents detail oriented, organized, quality driven and able to work in a team environment both national and international.
Tags for this Online Resume: Management, Data Queries, Metadata, CTMS- TMF
Clinical Quality Assurance
SUMMARY * 20+ years of experience in Quality Management and continuous improvement of quality, within Drug Safety, Clinical, Manufacturing, Regulatory Compliance and R &D domains of Bio-Pharmaceuticals * Conducted risk based Investigator site global audits including contract global central clinical labs * Conducted and Managed CRO's, 3rd party vendors / service providers for GCP and GvP compliance * Supported Internal and e...
Tags for this Online Resume: Services, Compliance, Infrastructure, Link Access Procedure (LAP), Research and Development, SDLC, Test, Packaging, Product Development, Quality
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
Quality Coordinator
Professional Summary: * Certified clinical research professional with nearly 10 years of clinical research experience in the medical device industry. I have a wide range of knowledge with site and study management having worked as an In-house/Field CRA, Lead CRA and Clinical Trial Assistant. * Conducting: Qualification, Initiation and Close-Out monitoring visits for pre and post-market trials. * Start-up activities for both...
Tags for this Online Resume: Documentation, Management, Data Management, Budgeting, Clinical Operations, Clinical Research, Collection, Compliance, Contract Negotiations, Distribution
I am a Regisered Nurse with interests and experience in Clinical Regional Monitoring and Clinical Management/Project Manager - 15 Years of Experience - Near 06512
I have a strong clinical background as a Registered Nurse prior to my joining the pharmaceutical industry. This has been beneficial in the course of my career. I have expertise in many areas and observational abilities in tracking subject safety and tolerability. I am aware of site challenges, having conducted clinical trials in large hospital settings as an RN and can be supportive and provide suggestions to sites when ch...
Ideal Companies: DOCs ICON Pfizer
Tags for this Online Resume: Clinical Research, Oncology, Immunology, Neuroscience, CRA, Registered Nurse, Clinical Manager, Data Management, Clinical Oversight, Project Management, CRO, CRO Oversight, GCP, ICH, Pharmaceutical Industry, Clinical Site Management, Compliance, Safety Management, Site Selection, Regulatory Compliance, Continuous Quality Improvement, Medical Writing, FDA Reporting, Trial Master File/eTMF, Cross-Functional Facilitation, Strategic Planning, Risk Analysis, Safety Oversight and Reporting, Data Targeted Review
Not Listed - 0 Years of Experience
3-years' experience coordinating and assisting in clinical trials monitoring activities * Sound knowledge of Good Clinical Practices (ICH-GCP) and FDA regulations * Vast experience in billing and coding, data management, data entry, conducting billing practices, and other administrative tasks * Familiar with various computerized coding programs and electronic health records. * Advanced medical/scientific knowledge and medi...
Tags for this Online Resume: Insurance, Audit, Compliance, Clinical Research, Data Management, Documentation, Filing, Management, Monitoring, Research
Clinical Research - 0 Years of Experience
Experienced in assisting Project Manager in Phase I - VI studies. Administrative, financial and technical support to the project manager and team members of assigned projects during any and all phases of the project (planning, initiation and closeout). Extensive knowledge of tracking and reporting programs. Training and set up of systems and policies. Extensive training and mentoring of team members. Assisted in set up of ...
Tags for this Online Resume: Management, Documentation, Scheduling, Support, Start up, Training, Project Management, Budgeting, Clinical Management, Clinical Operations
