CLINICAL RESEARCH of AMERICA (CRAA)Edison, NJ07/2014 to 11/2014
Recently Certified in Advanced Clinical Research and Drug Safety from Clinical Research Academy of America (CRAA), Edison, NJ.
Strong understanding of Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) Guidelines.
Knowledge of clinical research (Phase I-IV) processes, procedures and timelines.
Understanding of data management, statistical analysis process, clinical pharmacology concepts and scientific principles.
Hands on Working Knowledge of Oracle Clinical, Argus Safety, Designing/Reviewing CRFs.
BRISTOL-MYERS SQUIBBPrinceton, NJResearch Chemist01/1989 to 01/2013
Develop and deliver software requirements specifications and use cases for both user and system. Collaborate with business partners to understand the IT capabilities required by the business and identify business solutions by focusing on proactive as well as reactive problem solving. Proven ability to think strategically and implement tactically to execute operational business solutions.
15+ Years experience in a variety of software and business process improvement projects, as an independent contributor:
Communication and Collaboration through facilitating meetings, talking to stakeholders and end users, while understanding the business needs and solutions.
Requirements Specifications in the form of scope statements, use cases, business processes, product backlogs and user stories.
Diagram and Visual Modeling using white board drawings, workflow diagrams and wire frames utilizing Microsoft Visio BPMN.
Provide technical support improving client service perceptions by requirement gathering and testing for in-house and OTC software development projects from inception through design, implementation, operation, and continual improvement (ITIL).
Evaluate and reconstruct current processes. Examine and publish flows amongst teams, driving consistency and agreement. BRISTOL-MYERS SQUIBB, Business Analyst/Research Informatics Scientist )
Provide strong analysis, problem solving and decision making skills, ensuring that critical choices support the business.
Respond to change through Agile methodologies, where there is continuous customer/stakeholder involvement, early evidence of value through working deliverables, shortened project lifecycle times and higher quality by earlier feedback from customers ensuring better communication and trust.
Troubleshoot Tier III issues and advise on the appropriate action to be taken for a multi-disciplined field support staff responsible for various Help Desk functions including user support, systems analysis and customer service of R & D applications and platforms.
Point of communication between service users and the IT organization, improving service reliability, stability, and availability from receipt to resolution.
Log and track issues, using JIRA/vitalize/Remedy issue tracking systems.
Original team member and Administrator of the Electronic Notebook, enhancing, incorporating functionality and investigating opportunities for further application integrations with other laboratory information systems, which significantly increase productivity for scientists, peer reviewers, and supervisors in R&D.
Project related experience with several technologies: MS Office Word, Access, Excel, Project, and Visio; Electronic Notebook (Perkin Elmer); Chemical Database Systems; Pipeline Pilot; JIRA/vitalize/Remedy; Oracle Clinical 5.0.1; Oracle Argus 7.0.2; SQL; SAAS; and SharePoint. Solid background in the synthesis and design of biologically active molecules. Responsible for the synthesis of microsomal triglyceride transfer protein (MTP) and squalene synthetase inhibitors, with the goal being the preparation of cholesterol lowering compounds. Employed multi-step organic synthesis schemes, in which different lead compounds were probed. The most active compounds being hybrids of the leads. Both projects ended in the filing of a PLP. Proficient with flash chromatography, TLC, IR, HPLC, NMR and the interpretation of the data.
CYTOGEN CORPORATIONPrinceton, NJEXTERNSHIP - Worked in Quality Control01/1984 to 01/1989Princeton, NJ Directly responsible for successful synthesis of GYK-DTPA, the chelating agent used in Cytogen's proprietary technology of linking various anti-cancer agents to monoclonal antibodies. E.R.SQUIBB AND SONS (1984), New Brunswick, NJ EXTERNSHIP - Worked in Quality Control, testing finished products and making sure they complied with FDA standards.
International Institute of Business Analysis (IIBA) , Healthcare Business Women's Association (HBA) Member, American Chemical Society (ACS) Member, Toastmasters
Recently Certified in Advanced Clinical Research and Drug Safety from Clinical Research Academy of America (CRAA), Edison, NJ. DRUG SAFETY CERTIFICATION, CRAA, Edison, NJ ADVANCED CLINICAL RESEARCH CERTIFICATION, CRAA, Edison, NJ
Testing, Argus, Oracle, Chemistry, Access, Business Process Improvement, Cases, Customer Service, Database, Database Systems, Excel, Help Desk, Increase, Itil, Laboratory, Microsoft Sharepoint, Microsoft Visio, Ms Office, Pipeline, Proactive, Problem Solving, Process Improvement, Project Lifecycle, Receptionist, Remedy, Requirement Gathering, Retail Sales, Saas, Self Motivated, Sharepoint, Software As A Service, Software Development, Software Requirements, Solutions, Sql, Structured Software, Systems Analysis, Technical Support, Use Cases, User Stories, Visio, Word, Workflow, Chromatography, Filing, Flash, Hplc, Intermediate Representation, Ir, Leads, Nmr, Organic Synthesis, Antibodies, Fda, Monoclonal, Quality Control, Mba, Business Analysis, Healthcare, Clinical Research, Drug Safety, Clinical Pharmacology, Data Management, Gcp, Ich, Pharmacology, Statistical Analysis, Toxicology, Safety Certification
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