• A competent professional with an experience of 11.5 years in:
Clinical Database Programming Data/Team Management Clinical Research
Process Improvement Coordination & Liaison Project Management
• Currently designated as Lead Engineer 2 – with Pure Software Solutions and working as Project Consultant for the client, Oracle, Hyderabad.
• Diverse experience of working for world’s leading pharma companies and strong knowledge of best practices followed across these companies for Clinical Data Management
• Deft in interpreting & communicating required information to facilitate decision making process of the top management
• Experienced in planning & executing data capture and management tasks in a timely / accurate manner to ensure high level quality & productivity of Clinical Data Management
• Skilled in effectively managing documents for streamlining systems to facilitate achievement of organizational objectives
• Proficient at carrying out Clinical Research beyond established markets
• Effective at building & maintaining relationships with the stakeholders and with a quick TAT of their queries
• Possess excellent communication, innovative, planning, negotiation, analytical and problem solving skills
• Goal settings, appraisal discussions and identifying key development areas for Team Leads and their respective team members.
• Ensure that all the projects are implemented successfully, by reviewing documents and sending instructions to the implementation engineers for successful installation of project in Customer environment.
E. Sada Shiva Prasad has over 12 years of experience in clinical research and data management. He is currently a Lead Engineer at Pure Software Solutions working as a project consultant for Oracle India Pvt. Ltd. He has diverse experience working for major pharmaceutical companies and is proficient in clinical database programming, data management, project management, and ensuring compliance with regulations. He aims to take on a senior role in clinical research with a leading organization.
Bhavani R. has over 9 years of experience in clinical data management. She currently works as a Clinical Data Coordinator II at ICON Clinical Research, where her responsibilities include serving as study lead, mentoring staff, performing quality reviews, and ensuring data accuracy. Previously she held roles as a Senior Clinical Data Analyst at Syngene International and as a Senior Clinical Data Coordinator and Clinical Data Coordinator at Quintiles technologies, where she gained experience in tasks such as database design, query management, and data validation. She has worked on several clinical trials across various therapeutic areas and phases.
- Leland Joseph Eck is a results-driven senior project management professional with 27 years of experience successfully managing infrastructure, IT, and business projects.
- He has experience managing projects in industries such as automotive, manufacturing, healthcare, and financial services.
- His skills include project planning, execution, budget and schedule management, risk management, and strong communication abilities.
An accomplished project manager and health information management professional seeking a role utilizing experience managing HIM system implementations and conversions. Experience includes managing clinical documentation conversions, document archiving conversions, and testing integrations between HIM systems and third party applications. Provides expertise in areas such as project management, HIM operations, coding, health information systems, and team leadership.
Lila Killensworth has over 20 years of experience in the pharmaceutical industry, including expertise in clinical trial development, contracting, budgeting, and regulatory submissions. She has worked in managerial roles at several large pharmaceutical companies, where her responsibilities included negotiating contracts and budgets with investigative sites, developing regulatory submissions, and managing clinical operations. She has extensive experience in phases 1-4 clinical trials across multiple therapeutic areas.
Daniel Orr is seeking a senior software quality assurance lead/manager position with over 30 years of experience in software quality assurance, including test planning, execution, and reporting. He has extensive experience developing and monitoring test systems, processes, and procedures to ensure products meet requirements. Orr holds several certifications including in project management, database design, and software development. He aims to ensure products are delivered on time and on budget with the desired quality.
The document contains a career profile and resume for Denise Stream Deutchman, highlighting her extensive experience in leadership positions including IT Leader, project manager, and director roles across various industries such as Dell Computer Corporation, Cummins Inc., and Humana. She has a strong technical background and problem-solving skills, and her experience includes managing projects, teams, budgets, and process improvements using methodologies like Six Sigma. The resume provides details on her responsibilities, accomplishments, and skills in each role held from 1980 to the present.
This document provides a summary of Raghavendra S's career and qualifications. It outlines his 4 years of experience in clinical data management, knowledge of FDA and CDISC guidelines, and experience handling clinical trial data from various sources. It also lists his educational background, including an MSc in Applied Genetics and BSc in Biotechnology. Raghavendra has worked for several companies, including PPD and Quintiles, managing clinical trials and databases in therapeutic areas such as oncology, cardiology, and psychiatry.
E. Sada Shiva Prasad has over 12 years of experience in clinical research and data management. He is currently a Lead Engineer at Pure Software Solutions working as a project consultant for Oracle India Pvt. Ltd. He has diverse experience working for major pharmaceutical companies and is proficient in clinical database programming, data management, project management, and ensuring compliance with regulations. He aims to take on a senior role in clinical research with a leading organization.
Bhavani R. has over 9 years of experience in clinical data management. She currently works as a Clinical Data Coordinator II at ICON Clinical Research, where her responsibilities include serving as study lead, mentoring staff, performing quality reviews, and ensuring data accuracy. Previously she held roles as a Senior Clinical Data Analyst at Syngene International and as a Senior Clinical Data Coordinator and Clinical Data Coordinator at Quintiles technologies, where she gained experience in tasks such as database design, query management, and data validation. She has worked on several clinical trials across various therapeutic areas and phases.
- Leland Joseph Eck is a results-driven senior project management professional with 27 years of experience successfully managing infrastructure, IT, and business projects.
- He has experience managing projects in industries such as automotive, manufacturing, healthcare, and financial services.
- His skills include project planning, execution, budget and schedule management, risk management, and strong communication abilities.
An accomplished project manager and health information management professional seeking a role utilizing experience managing HIM system implementations and conversions. Experience includes managing clinical documentation conversions, document archiving conversions, and testing integrations between HIM systems and third party applications. Provides expertise in areas such as project management, HIM operations, coding, health information systems, and team leadership.
Lila Killensworth has over 20 years of experience in the pharmaceutical industry, including expertise in clinical trial development, contracting, budgeting, and regulatory submissions. She has worked in managerial roles at several large pharmaceutical companies, where her responsibilities included negotiating contracts and budgets with investigative sites, developing regulatory submissions, and managing clinical operations. She has extensive experience in phases 1-4 clinical trials across multiple therapeutic areas.
Daniel Orr is seeking a senior software quality assurance lead/manager position with over 30 years of experience in software quality assurance, including test planning, execution, and reporting. He has extensive experience developing and monitoring test systems, processes, and procedures to ensure products meet requirements. Orr holds several certifications including in project management, database design, and software development. He aims to ensure products are delivered on time and on budget with the desired quality.
The document contains a career profile and resume for Denise Stream Deutchman, highlighting her extensive experience in leadership positions including IT Leader, project manager, and director roles across various industries such as Dell Computer Corporation, Cummins Inc., and Humana. She has a strong technical background and problem-solving skills, and her experience includes managing projects, teams, budgets, and process improvements using methodologies like Six Sigma. The resume provides details on her responsibilities, accomplishments, and skills in each role held from 1980 to the present.
This document provides a summary of Raghavendra S's career and qualifications. It outlines his 4 years of experience in clinical data management, knowledge of FDA and CDISC guidelines, and experience handling clinical trial data from various sources. It also lists his educational background, including an MSc in Applied Genetics and BSc in Biotechnology. Raghavendra has worked for several companies, including PPD and Quintiles, managing clinical trials and databases in therapeutic areas such as oncology, cardiology, and psychiatry.
Steven Gross has over 30 years of experience in data analysis, modeling, and risk management. He holds a Bachelor's degree in Computer Science and has worked at several large financial institutions including GE Capital, Citigroup, JP Morgan Chase, and AT&T. Currently, Gross is a Senior Analyst at GE Capital where he is responsible for implementing risk models and ensuring data governance. He has a proven track record of innovation, leadership, and the ability to communicate technical information to non-technical audiences.
Richard Denker is a senior quality assurance analyst and consultant with over 20 years of experience in quality assurance testing and management. He has expertise in agile methodologies like Scrum and test automation tools. He is seeking to help companies improve their software quality and agile processes through consulting and quality assurance strategy development.
Lane Sherman is a professional project manager with 16 years of experience managing technical engineering projects, software validation projects, and space systems. He has a proven record of coordinating large, diverse projects and leading teams. His experience includes managing testing and evaluation efforts for the Missile Defense Agency and space-based models. He also has experience managing healthcare application testing teams and GPS engineering teams. Sherman holds an MBA and BS and is located in Colorado Springs, Colorado.
Heidi D. Kenty has over 13 years of experience in biologics manufacturing, including technical transfer and project management. She has a Master's in Business Administration and Bachelor's in Biotechnology. Her most recent role was at AstraZeneca/MedImmune as Senior Project Manager, where she led technical transfer projects for clinical and commercial products and established standard processes. Prior to that, she held various project management and technical roles at Bristol-Myers Squibb and the University of Rochester Medical Center.
Karen Buchaluk has over 20 years of experience in quality assurance, testing, and data management roles across several industries. She has a strong technical background with skills in SQL, databases, programming languages, and software testing tools. Her experience includes managing QA teams, implementing testing processes, analyzing requirements, developing test cases, performing various types of testing, and ensuring software quality. She has worked in agile environments and on projects involving new development, implementations, and system migrations.
An experienced IT professional with over 18 years of experience in areas such as IT management, database administration, project management, security, and ETL development. Skilled in technologies like Oracle, SQL Server, .NET, and Informatica. Provides leadership and delivers results for projects involving the design, development and maintenance of database solutions and information systems. Holds an MS in Information Technology Management and ITIL certification.
Jimmy Vale has over 6 years of experience in validation engineering for the pharmaceutical industry. He has extensive expertise in computer system validation, process validation, FDA regulations including 21 CFR Part 11, and validation documentation like validation plans and reports. He is proficient in testing tools like Mercury Quality Centre and Quick Test Professional. Currently he works as a Validation Analyst at Eisai, where he is leading the retrospective validation of a legacy inventory management system.
James Mayer is a senior technical systems lead with over 20 years of experience in software, hardware, and firmware development for wireless networks, satellite networks, broadband systems, and consumer electronics. He has a proven record of leading cross-functional teams to meet demanding business and technical requirements. Mayer is skilled in systems engineering, embedded Linux design, rapid prototyping, wireless network design, and project leadership. He has worked in commercial and defense environments for companies such as L3 Communications, General Micro Systems, DirecTV, Linquest Corporation, General Dynamics, Intel, and others. Mayer holds an MSEE from USC and a BSEE from UC Santa Barbara.
Herbert Lindsay is an experienced business development and quality assurance professional seeking a new role applying his strong software engineering and auditing skills. He has over 15 years of experience in software testing, quality assurance, and auditing roles at various financial and defense contracting firms. His background includes developing and executing testing plans, conducting audits, and implementing quality assurance processes. He is proficient in several programming languages, testing tools, and agile methodologies. He holds an MS in Computer Information Systems and certifications in quality assurance and CMMI.
Miss Abshari has extensive experience in quality assurance testing and software development. She is proficient in developing test plans, executing test scenarios, and documenting results. She has experience managing projects from start to finish, including requirements gathering, testing, deployment, and ensuring regulatory compliance. She possesses a Master's degree in Information Systems and Computer Security Management.
This document provides a summary of Robin Peterson's professional experience and qualifications. Robin has over 6 years of experience as a Validation Analyst in the life sciences industry. Robin has extensive experience with validation lifecycles, interacting with clients to define requirements, and generating validation documentation. Robin has worked at several pharmaceutical companies, leading validation projects and ensuring compliance with FDA regulations.
Harold Anthony Kom is a project manager with over 15 years of experience managing IT projects. He has managed projects for companies such as PT. Emerio Indonesia, PT Bank Commonwealth, and PT Jatis Mobile. Some of the projects he led include Prudential PRUForce Phase II New ODS implementation, FTP and RDM core banking upgrade projects, and Windows 7 migration projects. He holds a degree in Information Management and Computer Science and certifications in Cisco and Citrix administration.
Leland Newhauser is an experienced Quality Engineer with expertise in software, hardware, and firmware testing across various industries. He has over 15 years of experience authoring test cases, executing quality control processes, and ensuring high testing standards. His background includes testing roles at companies such as OLIM Technologies, Rockwell Automation, GE Healthcare, and Datatrak International.
The document is a resume for Brian E. Smith that outlines his experience and qualifications. It summarizes that he is an IT and integration management professional with over 21 years of experience leading projects from conception to completion. He is currently the Manager of Process Integration at DuPont in Kansas where he leads IT application development and support activities. Previously he held roles such as Senior Specialist at the University of Kansas Medical Center and Senior Application Developer/Analyst at Universal Underwriters Group.
As an expert provider of a wide spectrum of clinical development support services, KCR has developed
a supreme Data Management (DM) solution geared towards full data transparency as well as
delivering the highest level of quality within the defined timelines and in adherence to study budgets,
all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements. Read our DM brochure and learn more about KCR DM capabilities.
Mohammed Ayyad's resume lists his objective of seeking a creative and ambitious organization to utilize his project management and engineering experience. It provides details of his professional experience including roles as an Optimization Engineer, Project Manager, and Product Development Manager on various projects in Kuwait and Jordan. The resume also outlines his education and various technical courses completed.
This document provides an overview of audits and inspections for quality management in life sciences. It defines audits and inspections, describes types of each, and outlines focus areas. Key aspects of audits covered include classification of findings, root cause analysis, corrective action processes, audit tools, and dos and don'ts. Good documentation practices, risk management, and escalation management processes are also summarized. The purpose is to educate on quality policy, audits, inspections, and related quality management topics in life sciences.
Kazi Hossain has over 10 years of experience in manual and automated testing for web applications. He has expertise in test planning, developing test cases, scripting automated tests in VBScript using tools like QTP and UFT, executing regression test suites, and tracking bugs. He has extensive experience testing applications in the banking, healthcare, and middleware domains across Windows and Mac environments.
Book displays are a great way to highlight underused collections, increase circulation, and to encourage discovery in your library. In this free webcast with Susan Brown, director of the Chapel Hill Public Library and Nancy Dowd, co-author of ALA’ s best-selling book, Bite-Sized Marketing: Realistic Solutions for Overworked Librarians, we'll show you how you can create book displays that will leave readers asking for more.
Steven Gross has over 30 years of experience in data analysis, modeling, and risk management. He holds a Bachelor's degree in Computer Science and has worked at several large financial institutions including GE Capital, Citigroup, JP Morgan Chase, and AT&T. Currently, Gross is a Senior Analyst at GE Capital where he is responsible for implementing risk models and ensuring data governance. He has a proven track record of innovation, leadership, and the ability to communicate technical information to non-technical audiences.
Richard Denker is a senior quality assurance analyst and consultant with over 20 years of experience in quality assurance testing and management. He has expertise in agile methodologies like Scrum and test automation tools. He is seeking to help companies improve their software quality and agile processes through consulting and quality assurance strategy development.
Lane Sherman is a professional project manager with 16 years of experience managing technical engineering projects, software validation projects, and space systems. He has a proven record of coordinating large, diverse projects and leading teams. His experience includes managing testing and evaluation efforts for the Missile Defense Agency and space-based models. He also has experience managing healthcare application testing teams and GPS engineering teams. Sherman holds an MBA and BS and is located in Colorado Springs, Colorado.
Heidi D. Kenty has over 13 years of experience in biologics manufacturing, including technical transfer and project management. She has a Master's in Business Administration and Bachelor's in Biotechnology. Her most recent role was at AstraZeneca/MedImmune as Senior Project Manager, where she led technical transfer projects for clinical and commercial products and established standard processes. Prior to that, she held various project management and technical roles at Bristol-Myers Squibb and the University of Rochester Medical Center.
Karen Buchaluk has over 20 years of experience in quality assurance, testing, and data management roles across several industries. She has a strong technical background with skills in SQL, databases, programming languages, and software testing tools. Her experience includes managing QA teams, implementing testing processes, analyzing requirements, developing test cases, performing various types of testing, and ensuring software quality. She has worked in agile environments and on projects involving new development, implementations, and system migrations.
An experienced IT professional with over 18 years of experience in areas such as IT management, database administration, project management, security, and ETL development. Skilled in technologies like Oracle, SQL Server, .NET, and Informatica. Provides leadership and delivers results for projects involving the design, development and maintenance of database solutions and information systems. Holds an MS in Information Technology Management and ITIL certification.
Jimmy Vale has over 6 years of experience in validation engineering for the pharmaceutical industry. He has extensive expertise in computer system validation, process validation, FDA regulations including 21 CFR Part 11, and validation documentation like validation plans and reports. He is proficient in testing tools like Mercury Quality Centre and Quick Test Professional. Currently he works as a Validation Analyst at Eisai, where he is leading the retrospective validation of a legacy inventory management system.
James Mayer is a senior technical systems lead with over 20 years of experience in software, hardware, and firmware development for wireless networks, satellite networks, broadband systems, and consumer electronics. He has a proven record of leading cross-functional teams to meet demanding business and technical requirements. Mayer is skilled in systems engineering, embedded Linux design, rapid prototyping, wireless network design, and project leadership. He has worked in commercial and defense environments for companies such as L3 Communications, General Micro Systems, DirecTV, Linquest Corporation, General Dynamics, Intel, and others. Mayer holds an MSEE from USC and a BSEE from UC Santa Barbara.
Herbert Lindsay is an experienced business development and quality assurance professional seeking a new role applying his strong software engineering and auditing skills. He has over 15 years of experience in software testing, quality assurance, and auditing roles at various financial and defense contracting firms. His background includes developing and executing testing plans, conducting audits, and implementing quality assurance processes. He is proficient in several programming languages, testing tools, and agile methodologies. He holds an MS in Computer Information Systems and certifications in quality assurance and CMMI.
Miss Abshari has extensive experience in quality assurance testing and software development. She is proficient in developing test plans, executing test scenarios, and documenting results. She has experience managing projects from start to finish, including requirements gathering, testing, deployment, and ensuring regulatory compliance. She possesses a Master's degree in Information Systems and Computer Security Management.
This document provides a summary of Robin Peterson's professional experience and qualifications. Robin has over 6 years of experience as a Validation Analyst in the life sciences industry. Robin has extensive experience with validation lifecycles, interacting with clients to define requirements, and generating validation documentation. Robin has worked at several pharmaceutical companies, leading validation projects and ensuring compliance with FDA regulations.
Harold Anthony Kom is a project manager with over 15 years of experience managing IT projects. He has managed projects for companies such as PT. Emerio Indonesia, PT Bank Commonwealth, and PT Jatis Mobile. Some of the projects he led include Prudential PRUForce Phase II New ODS implementation, FTP and RDM core banking upgrade projects, and Windows 7 migration projects. He holds a degree in Information Management and Computer Science and certifications in Cisco and Citrix administration.
Leland Newhauser is an experienced Quality Engineer with expertise in software, hardware, and firmware testing across various industries. He has over 15 years of experience authoring test cases, executing quality control processes, and ensuring high testing standards. His background includes testing roles at companies such as OLIM Technologies, Rockwell Automation, GE Healthcare, and Datatrak International.
The document is a resume for Brian E. Smith that outlines his experience and qualifications. It summarizes that he is an IT and integration management professional with over 21 years of experience leading projects from conception to completion. He is currently the Manager of Process Integration at DuPont in Kansas where he leads IT application development and support activities. Previously he held roles such as Senior Specialist at the University of Kansas Medical Center and Senior Application Developer/Analyst at Universal Underwriters Group.
As an expert provider of a wide spectrum of clinical development support services, KCR has developed
a supreme Data Management (DM) solution geared towards full data transparency as well as
delivering the highest level of quality within the defined timelines and in adherence to study budgets,
all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements. Read our DM brochure and learn more about KCR DM capabilities.
Mohammed Ayyad's resume lists his objective of seeking a creative and ambitious organization to utilize his project management and engineering experience. It provides details of his professional experience including roles as an Optimization Engineer, Project Manager, and Product Development Manager on various projects in Kuwait and Jordan. The resume also outlines his education and various technical courses completed.
This document provides an overview of audits and inspections for quality management in life sciences. It defines audits and inspections, describes types of each, and outlines focus areas. Key aspects of audits covered include classification of findings, root cause analysis, corrective action processes, audit tools, and dos and don'ts. Good documentation practices, risk management, and escalation management processes are also summarized. The purpose is to educate on quality policy, audits, inspections, and related quality management topics in life sciences.
Kazi Hossain has over 10 years of experience in manual and automated testing for web applications. He has expertise in test planning, developing test cases, scripting automated tests in VBScript using tools like QTP and UFT, executing regression test suites, and tracking bugs. He has extensive experience testing applications in the banking, healthcare, and middleware domains across Windows and Mac environments.
Book displays are a great way to highlight underused collections, increase circulation, and to encourage discovery in your library. In this free webcast with Susan Brown, director of the Chapel Hill Public Library and Nancy Dowd, co-author of ALA’ s best-selling book, Bite-Sized Marketing: Realistic Solutions for Overworked Librarians, we'll show you how you can create book displays that will leave readers asking for more.
Este documento contiene la actividad de reconocimiento de un estudiante en un curso de inglés en línea. El estudiante describe cada uno de los entornos del curso y cómo le ayudan en su aprendizaje. También saluda a su tutor y compañeros en el foro de reconocimiento.
This document is an advertising proposal from Direct Media USA for out-of-home transit advertising. It outlines two plans for a 20-week campaign, including the number and types of displays, pricing details, and examples of the bus shelter, train windscreen, and king displays that would be used.
Este documento proporciona instrucciones sobre cómo iniciar Excel 2010 y describe los componentes principales de la pantalla inicial de Excel. La sección 1 explica cómo iniciar Excel 2010 desde el menú Inicio o desde Microsoft Office. La sección 2 describe los elementos fundamentales de la pantalla inicial como la ficha Archivo, las barras de título y de acceso rápido. La sección 3 explica que la ficha Archivo contiene opciones para crear, guardar e imprimir documentos. La sección 4 describe que la barra de título muestra el nombre del archivo y la barra de acceso rá
Earthling Interactive is a custom software development company that has been in business for over 13 years. It has a staff of 25 with an average of 7.5 years of experience who specialize in creating scalable, data-driven web and mobile applications for business clients. Some of Earthling Interactive's clients and projects mentioned include developing an engagement application for a rehabilitation center, a freight auction application, a manufacturing order and installation tracking tool, agricultural and vehicle tracking tools for John Deere, a curriculum management application used by hundreds of thousands of students, several applications for nursing home management, and a mobile energy conversion tool.
Brett Finlay has over 20 years of experience in the LP Gas industry in roles involving business development, account management, branch management, and operations management. He is currently a Business Representative for Kleenheat Gas in Queensland, where he is responsible for maintaining sales budgets, developing new business opportunities, and achieving performance targets. Prior to this, he held roles such as Dealer Manager and Branch Manager/Operations Supervisor, where he oversaw dealer site operations, managed staff, and was responsible for daily operations. He aims to build strong customer relationships while pursuing volume and margin growth.
Adolescent marriage is common in Guatemala, especially in rural areas, where over half of women aged 20-24 were married before 18. Factors contributing to this problem include lack of access to education and reproductive healthcare, poverty, and traditional beliefs. Child marriage often leads to negative consequences such as early pregnancy and childbirth complications, high rates of domestic abuse, sexually transmitted diseases, and school dropout. Improving access to education, healthcare, and economic opportunities could help address this issue.
This document discusses strategies for meeting the needs of diverse learners in the classroom. It addresses linguistic, cultural, and cognitive diversity. Some key points include: building relationships with students; using primary language support, sheltered instruction, and instructional conversations; understanding the differences between basic interpersonal communication skills and cognitive academic language proficiency; promoting inclusion and considering students' least restrictive environments; and using assessments to inform instructional practices. The overall message is the importance of utilizing a variety of instructional strategies and beliefs to effectively educate students with diverse needs and backgrounds.
Este documento contiene la actividad de reconocimiento de un estudiante en un curso de inglés en línea. El estudiante describe cada uno de los entornos del curso y cómo le ayudan en su aprendizaje. También saluda a su tutor y compañeros en el foro de reconocimiento.
Behavior studies show that more and more people visiting libraries want to find materials and information on their own. This presents a challenge for librarians: how can they best help these self-directed readers? While many libraries use traditional strategies with book displays and bibliographies, today’s readers need more. This webinar will share the latest results of patron browsing behaviors and offer innovative practices to help you engage patrons with passive programming ideas and self-directed pathways.
#BeyondBookDisplays
Este documento presenta los pasos de una práctica de Excel que incluye seleccionar una cuadrícula, usar series y repetición, agregar bordes y centrar celdas, y completar un trabajo final.
Este documento presenta los pasos de una práctica de Excel que incluye seleccionar una cuadrícula, usar series y repetición, agregar bordes y centrar celdas, y completar un trabajo final.
El documento habla sobre los rellenos uniformes en la unidad 5. Menciona que los rellenos uniformes son mezclas de colores que crean armonías y que el relleno uniforme es una mezcla de colores.
This document provides summaries for 10 projects across various mediums including publications, branding, packaging, typefaces and websites. The projects address problems such as representing African culture positively, updating a state park's branding, designing for a professor's book on PTSD, and creating tea packaging that conveys British culture. The solutions generally involve using design elements like color, imagery and layout to achieve specific tones and convey intended messages through the different mediums.
The document is a bucket list created by Joshua Paez Cadavez detailing personal goals in various areas of life including career, hobbies, travel, and family. It was inspired by the bucket lists of two of Joshua's role models, Dr. Chris E. Stout and Markiplier, who demonstrated achieving goals while finding happiness. Joshua challenges readers to make their own lists and start accomplishing goals, as life is short. The extensive bucket list contains over 200 specific milestones across diverse domains.
Sandra Frazilus has over 10 years of experience in clinical data management. She received an MBA in operations management and a BSBA in project management. Currently, she is a senior clinical data manager at I3 Statprobe, where she oversees data management projects and supervises staff. Previously, she held data management roles at Pfizer and Bayer Biological/Talecris Biotherapeutics. Her experience includes phases I-IV clinical trials across several therapeutic areas.
Lanka Praneeth is seeking a career opportunity in a progressive organization where he can apply his knowledge and skills. He has over 7 years of experience in clinical research roles including project manager, data analyst, site service specialist, trainee CRA, and clinical research coordinator. His experience includes responsibilities like study planning, financial and regulatory documents, sample tracking, data management, discrepancy management, and ensuring compliance. He has a master's degree in biotechnology and postgraduate qualifications in clinical research and lab techniques.
Namitha Rajashekar is a Data System Designer with over 4 years of experience in database design and 1.5 years of experience in Spotfire. She has expertise in Medidata Rave and understanding of clinical research operations and various therapeutic areas. She is proficient in SQL, HTML, Inform eCRF, and has knowledge of TIBCO products including Spotfire Professional, Spotfire Webplayer, and Spotfire Server. She is currently working as a Data System Designer at Pharm-Olam International and has previous experience working as a Spotfire Programmer and Rave Programmer at Quintiles and as a Clinical Database Developer at Accenture.
Narasimha Praveen Kumar Bodha is a QA Sr Consultant with over 6 years of experience in software testing including ETL/DW testing, database testing, and manual/functional QA testing. He has worked on various projects for clients like Genetech, BCBSNC, United Health Group, and Microsoft. Some of his key responsibilities include requirement analysis, test case development, test execution, defect tracking, preparing test plans and reports, and providing production support. He is proficient with tools like SQL Server, Abinitio, Rally, VSTS, MTM, QC, and has expertise in Agile testing methodologies.
Sandesh Kadam is seeking a position that allows him to use his 13 years of experience in project management, software testing, and quality assurance. He has managed teams of up to 12 people and has experience testing software applications in the capital markets and banking industries. He is proficient in Agile methodologies like Scrum and has experience with manual and automated testing tools like Selenium and QTP.
This document provides a summary of Philip Morganti's skills and professional experience as a Project Manager specializing in healthcare projects. It outlines his role leading implementation teams for clinical software at Broward Health from 2012 to present. It also details his previous experience as a Senior Project Manager at MedStar Health from 2001 to 2012 and as a Project Manager at Superior Consultants from 1998 to 2001 where he managed several healthcare projects. His education includes a Bachelor of Science in Medical Technology from Fredonia State University.
This summary provides an overview of Yvette Burgess's experience in 3 sentences:
Yvette Burgess has over 16 years of experience in software testing across various industries including health insurance, mortgage banking, utilities, and energy. She has extensive experience leading testing teams and projects using tools like HP Quality Center, Jira, and ClearQuest. Her background includes roles as a test lead, quality analyst, and testing specialist with a focus on test automation, defect management, and ensuring software quality.
Priyanka Agarwal is seeking a position that allows her to utilize her 8.4 years of experience in clinical data management. She has worked as an analyst, programmer/analyst, and clinical database programmer at Quintiles Technologies since 2011. Her technical skills include Oracle InForm and Central Designer, and she has experience designing eCRFs, programming edit checks, and performing post-production changes. She holds a Master's degree in Business Administration and Bachelor's degree in Bio-Technology.
Alyssa Andreen is a clinical research project manager at DaVita Clinical Research in Lakewood, Colorado. She has over 8 years of experience in clinical trials and previously worked as a dialysis technician/administrative assistant at DaVita Dialysis. Her responsibilities include assisting with IRB applications, setting up clinical trial sites, creating and maintaining regulatory documents, training and supervising staff, and ensuring studies are conducted according to protocols and regulations. She is currently working towards her BA at Metropolitan State University of Denver and has an Associate's degree from Red Rocks Community College.
Kimberly Caller is a business analyst with experience in project management, business process improvement, and software development. She has a master's certificate in management information systems and has designed inventory tracking, mobile healthcare, and chemical distribution systems. Her skills include requirements analysis, process modeling, and ensuring compliance with industry standards like GLP, cGMP, and ISO. She currently works as a business systems analyst at CommunityAmerica, where she facilitates agile development and improves business operations.
Roshan Kumar S is a Clinical Process Associate-2 with 1.8 years of experience in clinical research. He has thorough knowledge of clinical trials, ICH-GCP guidelines, and medical terminology. His roles include performing administrative tasks, assisting with data management, establishing communications, and ensuring documentation quality. He also monitors studies and communicates with clients, and has skills in computer programs, analytics, communication, and time management.
Anthony Bordley has over 20 years of experience in software quality assurance, testing, project management, and business analysis. He has led QA teams and developed testing processes for companies like VWR International, Apex Systems, and Bank One. Bordley has expertise in a variety of testing techniques including manual testing, test automation, defect tracking, and risk assessment. He is proficient in many programming languages, testing tools, and project management methodologies.
Deanna Goodwin Mouser has over 20 years of experience in clinical research and real estate. She holds a B.A. in Sociology from California State University Northridge and has completed an online course in human subjects research from UCLA. Currently she works as a licensed real estate agent at Keller Williams in Burbank, CA. Previously she held various roles managing clinical research studies and projects, including as a Project Manager at Quest Diagnostics and Associate Project Director at the California Family Health Council. She has extensive experience designing studies, managing teams, and ensuring compliance with protocols and regulations.
Ken Boyles has over 20 years of experience in radiology information systems and Epic implementations. He has worked as an Epic consultant, leading builds for Radiant and Cardiant modules. His experience includes workflow analysis, system builds, testing, and training. He has successfully implemented systems at multiple hospitals and healthcare organizations.
SibSankar Bag has over 6 years of experience in quality assurance involving analysis and manual/automated testing of client data warehouses and ETL processes at Tata Consultancy Services. He has extensive experience testing data warehouses and ETL processes using tools like Informatica and Teradata. He is proficient in SQL, PL/SQL, test planning, defect management, and agile/waterfall methodologies. Currently he works as a test analyst for AmerisourceBergen Corp.'s master data management project involving Informatica MDM.
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1. E. SADA SHIVA PRASAD
Mobile: +91-9160004925, +91-8332914035 ~ E-Mail: / essprasad@gmail.com
Job Objective
Seeking senior level assignments in Clinical Research with a leading organization of high repute
Profile Summary
A competent professional with an experience of 11.5 years in:
Clinical Database Programming Data/Team Management Clinical Research
Process Improvement Coordination & Liaison Project Management
Currently designated as Lead Engineer 2 – with Pure Software Solutions and working as Project Consultant for the
client, Oracle, Hyderabad.
Diverse experience of working for world’s leading pharma companies and strong knowledge of best practices followed
across these companies for Clinical Data Management
Deft in interpreting & communicating required information to facilitate decision making process of the top management
Experienced in planning & executing data capture and management tasks in a timely / accurate manner to ensure high
level quality & productivity of Clinical Data Management
Skilled in effectively managing documents for streamlining systems to facilitate achievement of organizational objectives
Proficient at carrying out Clinical Research beyond established markets
Effective at building & maintaining relationships with the stakeholders and with a quick TAT of their queries
Possess excellent communication, innovative, planning, negotiation, analytical and problem solving skills
Goal settings, appraisal discussions and identifying key development areas for Team Leads and their respective team
members.
Ensure that all the projects are implemented successfully, by reviewing documents and sending instructions to the
implementation engineers for successful installation of project in Customer environment.
Core Competencies
Protocol understanding and its interpretation in specifications, Designing eCRF, edit check programming (front end
and backend), UAT, Go-Live and Data Management activities using Central Designer, Medidata Rave, Inform Architect,
PhosCo tools, External Data Management, Data integration across different databases, conversion of custom data into
SDTM datasets, SDTM datasets review and updation
Leading the development of specifications, implementation and testing for the development of eCRF
Writing / reviewing detailed reports explaining about quality & its results, in terms of clinical research conducted;
creating and collating relevant documentation regarding the same
Compiling data, innovating analysis & identifying the observed trends in data; conducting web search for required
data and analyzing the collected data
Mapping documents with the information provided and forwarding it to the management to intimate about the basic
understanding of data
Providingprocess improvementwithafocus onstreamlining process by adding value to the business & meeting client needs
Coordinating & liaising with TA Lead, Medical Coder, Clinical Data Manager, Clinical Database Programmer & Clients
Identifying team’s training & development needs and conducting appropriate training programmes to enhance their skills
Performing Objective settings for the Team Leads, constant follow-up, appraisal discussions followed by performance
ratings.
Organisational Experience
Since Jan’14 Pure Software Solutions, Hyderabad as Lead Engineer – Resource Consultant – Client –Oracle India
Pvt. Ltd., Hyderabad.
Role:
Co-ordinating with Project Managers, Design Consultants, Technical Consultants, SDMs, Dev and QA Leads, for every
US project on weekly calls.
Responsible for smooth delivery of projects (Inform Fast Starts and Fast Forwards) from resourcing point of view.
Keep the communication intact with US collegues to match with US timings by working in night shift and respond to
their queries in time.
Provide the weekly status report for all the projects to the higher management.
Provide update on the upcoming projects’ pipeline.
Alert the higher management well-in advance of the potential upcoming risk with projects or with resourcing.
Manage off-shore resourcing including leaves, internal shuffles, trainings, project-plan updates etc.., with focus on
project deliveries.
Provide inputs on process improvement to the management.
2. Rolling out an updated resource sheet every day for the team to work on different projects.
Performing Trial development activities as per the clients’ requirements including Post-Go Live changes.
Highlights:
Worked on 196 total clarity requests for US region (26-FS,51-COs,60-TCCs,Scoping–38-21others)
Worked on 500+ requests to raise CRQs through PhaseForward Remedy for UAT, LIVE and TRN environments.
Received “High Flier” award from Pure Software Solutions as a token of appreciation
Received appreciations from my Director I am reporting to, and US PMs for good performance.
Worked on 1500+ UAT/Live/TRN CRQs with 100 % quality.
Jan’11-Jan’14 Tata Consultancy Services, Mumbai as IT Analyst – Lead Clinical Data Manager
Role:
Developing full understanding of protocol including study documentation
Preparing Quality Control Plan
Gathering requirements for quality deliverable from the client
Sending project plan to client after revising on regular basis
Reviewing eCRF specifications prepared by Clinical Data Manager/ Clinical Database Programmer and finalizing guidelines
Re-evaluatingprotocol deviationdocument;DVRspecifications;teststeps;UAT plan, performance& report; DMP Metrics; etc.
Providing access in the:
o Preparation of Data Transfer Agreement for Vendors, SAE reconciliation and vendor data reconciliation
o Monitoring data listings programs and dataset reviews for patient data consistency, quality & completeness
Managing discrepancy in accordance with the agreed timelines on front end checks, programmed consistency checks
(back end)and escalating them in the clinical data to TA Lead & Clients as appropriate
Conducting studies for identifying issues with validation procedures and communicating the findings to TA Lead & Client
Interfacing& interactingwithTALead, sites, monitors,colleaguesandclientforsitedatarelatedprocesses/issues like dataflow
Utilizing appropriate data management tools to monitor quality & timeliness of data flow for assigned site
Ensuring error free & quality data with no open queries before database lock, ICH GCP regulations and SOPs are
adhered to for data management activities
Delivering applicable & required study metrics to Therapeutic Lead/ Project Manager
Preparing the team members for audit ready documentation throughout the trial
Attending relevant study teleconference with Clinical Data Managers & Client
Updating Metrics (Snap Shots) on regular basis and send it to the team & internal customers
Highlights:
Actively worked in Global Data Transfer Agreement for Bio Marker Data & Listings Programs for the client
Instrumental in streamlining the Clinical Database programming and Quality Testing process in the project
Received appreciations and promoted to next level for efficiently handling the assigned tasks
Played a vital role in developing Global Library checks for the client on Central Designer tool
Sep’07–Jan’11 Novartis Healthcare Pvt. Ltd., Hyderabad, AP as EDC Trial Builder
Role:
Involved in developing & programming EDC trials in PhosCo, Oracle Clinical, Central Designer tools for global Vaccines
Development clinical trials, phases I to IV, by setting up eCRFs, programming associated edit checks & data variable
mappings for data extraction based on specifications provided by the Clinical Data Coordinators
Carried out thorough development testing (point-to-point) and delivered EDC trial packages & reports that are ready
for user acceptance testing
Developed GRT reports by using SQL/PLSQL programming as per the requirement
Outsourced studies to the CROs (Parexel, CMed, Covance, PPD & Quintiles) and guided them regarding study requirements
Responsible for working on SOP preparation for the entire CRO trial designing process
Worked for central lab external data loading into Novartis CT4 Database
Supervised & monitored new joinees for handling CRO & EDC studies
Highlights:
Received an Above and Beyond Award for working on global reports using SQL & PL/SQL
Worked on creation of SOP on CRO trials management
Oct’06–Sept’07 Accenture Services Pvt. Ltd., Bangalore, Karnataka as Study Builder
Role:
Created eCRFs using inform architect and associate appropriate edit checks
Produced collation list & packages
Coordinated & interacted with the global team members for uniformity of the study all over on regular basis
3. Carried out peer review for all forms & rules
Highlight:
Successfully created Study Specific Library by collecting study specific checks across trials of different therapeutic
areas
Feb’05–Oct’06 Biological E. Ltd., Hyderabad, Andhra Pradesh as Junior Scientific Officer
Role:
Responsible for clinical lot production of Cell Culture based Measles Vaccine by using Chicken Embryo Fibroblast cells
Carried out following activities for Cell Culture based JE & Dengue Vaccines:
o Revival of VERO, MDCK, MRC-5, PS etc., Cells
o Subculture & Cell Banking
o Sterility Checking of Cells by Soya & Thio Broths
o Mycoplasma Detection in Cell Cultures
o Estimating DNA & Protein Content of Cells
o Antigen Detection by ELISA
o SDS-Page
o Counting the number of Cells in each Flask
o Literature Survey of Cell History
o Preparation of Media, Reagents, Buffers, Trypsin, PBS, Sterility Media, etc.
o Monitoring Area Cleaning, Equipment Cleaning & Sterilization Records
o Inventory Control
Highlights:
Major Instruments Handled:
o Autoclave (Production Scale)
o ELISA Reader (BioRad)
o Lyophiliser (Virtis)
o SDS-Page Unit (BioRad)
o Spectrophotometer (Shimadzu)
o Refrigerated Centrifuge (Beckmann)
Previous Experience
Jun’04-Dec’04 Biomed Informatics, Hyderabad, Andhra Pradesh as Research Associate
Trainings
Inform Architect
Central Designer
Medidata Rave
Clinical Data Management
PL/SQL
SAS 9.0
Bio-informatics
Education
2011 MBA (HR) from Osmania University, Hyderabad
2004 Advanced PG Diploma in Bioinformatics from Medwin Hospitals, Hyderabad
2004 M.Sc. (Biotechnology) from Ganga Kaveri Institute of Science and Management (GKISM), Bangalore University,
Bangalore
2002 B.Sc. from S.R.R. Govt. Degree College, Kakatiya University, Karimnagar
Certification:
SAS Certified
C#, .NET certification from Aptech
IT Skills
MS Office: Word, PowerPoint & Excel, Ms Project
Tools Used: Inform Architect, Central Designer, Medidata RAVE, Oracle Clinical,
Clintrial, Novartis EDC, I-Review & GPS-II, Clarity-PPM
Languages: C & VBScript, C# and .NET
4. EXTRACURRICULAR ACTIVITIES
Served as Member of Corporate Cricket Team at Novartis
Functioned as Cultural Secretary at GKISM, Bangalore
Won various awards at School and College levels in sports, elocution, essay writing and quiz competitions
Active participation in corporate cultural activities
Social Engagement
Voluntarily donated funds to Parivartan Sandesh Foundation, NGO and Relief India Trust
Served as Member of Green Peace, India
Voluntary funds contribution to TCS Welfare Trust
Personal Details
Date of Birth: 10th August, 1980
Present Address: Door No. 9-7-211/102, Shanta Lakeview Apartment, Near Mansarovar Heights, Manovikas
Nagar, Secunderabad, Telangana – 500009
Permanent Address: Door No. 9-7-211/102, Shanta Lakeview Apartment, Near Mansarovar Heights, Manovikas Nagar,
Secunderabad, Telangana – 500009
Languages Known: English, Hindi, Telugu, Kannada & Marathi
Location Preference: Hyderabad