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Online Resumes with "TMF"

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

Manager - 20 Years of Experience - Near 95014

Summary * Lead Enterprise Architect * Digital Transformation & Transition Architect * Business Requirements Head * Solution/Integration/Data - Architect * Business Analyst * Development Lead / Developer Focus Areas * Transformational Programs * Business, Integration & Enterprise Architecture * Global IT Outsourcing / Transition IT Strategy & Governance * ADM & Managed Services Delivery Significant International Multisite ( ...

Tags for this Online Resume: Nortel, Outsourcing, Data Management, Management, POS, Unified Modelling Language, Architect, ATG, BEA Tuxedo, BEA WebLogic

Payroll Administrator - 3 Years of Experience - Near 30228

Profile Payroll Specialist handling multi - million-dollar client payroll such as Phoenix House, Cole Haan, Coca Cola, and Duracell. Diversified customer service professional providing world class customer service to both external and internal customers. Expertise in fast track banking, billing and financial service industry with transferable skills that can be utilized in any customer oriented organization. Strong work eth...

Tags for this Online Resume: Accounts Payable, Apple Newton, Banking Industry, Billing, Call Center, Credit Card, Customer Service, Data Entry, Deductions

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 Research - 16 Years of Experience - Near 94547

SUMMARY of QUALIFICATIONS 16 years of experience as a Clinical Research professional in Biotech and Pharmaceutical industries. Well-rounded skill, as a CRA in Clinical Operations processes, Clinical Development, Regulatory, TMF and Data Management. Skilled in data audit/review Study start up, Study conduct, Vendor management, and Site monitoring activities extensive knowledge of GCP-ICH, GLP, GMP guidelines familiar with Ex...

Tags for this Online Resume: Protocol, Assessments, Audit, Clinical Research, Documentation, Pediatrics, Research, Clinical Management, Distribution, oncology, phase, trial, clinical, protocol, pharmaceutical, gcp, ich

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 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

Featured Profile

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

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