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| clinical project management courses: Clinical Trial Project Management Ashok Kumar Peepliwal, 2023-11-15 Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. Covers how to conduct clinical trials in detail Present useful, basic, and advanced statistical tools Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book |
| clinical project management courses: The Comprehensive Guide To Clinical Research Chris Sauber, Dan Sfera, 2019-04-21 Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps |
| clinical project management courses: A Practical Guide to Managing Clinical Trials JoAnn Pfeiffer, Cris Wells, 2017-05-18 A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is A View from India, a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials. |
| clinical project management courses: Pharmaceutical and Biomedical Project Management in a Changing Global Environment Scott D. Babler, 2011-01-06 Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers. |
| clinical project management courses: Clinical Trial Project Management Martin Robinson, Helena Korjonen, 2008 Clinical research projects are frequently complex and may have a large element of uncertainty both during their conduct and in their final outcome. This book sets out to give tools and techniques to plan, track and conrol projects in clinical research. |
| clinical project management courses: Project Management for Research Adedeji B. Badiru, Christina F. Rusnock, Vhance V. Valencia, 2018-09-03 Graduate research is a complicated process, which many undergraduate students aspire to undertake. The complexity of the process can lead to failures for even the most brilliant students. Success at the graduate research level requires not only a high level of intellectual ability but also a high level of project management skills. Unfortunately, many graduate students have trouble planning and implementing their research. Project Management for Research: A Guide for Graduate Students reflects the needs of today’s graduate students. All graduate students need mentoring and management guidance that has little to do with their actual classroom performance. Graduate students do a better job with their research programs if a self-paced guide is available to them. This book provides such a guide. It covers topics ranging from how to select an appropriate research problem to how to schedule and execute research tasks. The authors take a project management approach to planning and implementing graduate research in any discipline. They use a conversational tone to address the individual graduate student. This book helps graduate students and advisors answer most of the basic questions of conducting and presenting graduate research, thereby alleviating frustration on the part of both student and advisor. It presents specific guidelines and examples throughout the text along with more detailed examples in reader-friendly appendices at the end. By being more organized and prepared to handle basic research management functions, graduate students, along with their advisors, will have more time for actual intellectual mentoring and knowledge transfer, resulting in a more rewarding research experience. |
| clinical project management courses: Project Management for the Pharmaceutical Industry Laura Brown, Tony Grundy, 2016-04-08 The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management. |
| clinical project management courses: A Clinical Trials Manual From The Duke Clinical Research Institute Margaret Liu, Kate Davis, 2011-08-24 The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nuts and bolts approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. |
| clinical project management courses: Designing Clinical Research Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman, 2011-11-30 Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly. |
| clinical project management courses: Building the Clinical Research Workforce: Challenges, Capacities and Competencies Carolynn Thomas Jones, Barbara E. Bierer, Stephen Sonstein, Hazel Ann Smith, Denise Snyder, 2024-08-05 This is an unprecedented time for clinical research. The number and complexity of clinical research studies have increased significantly in the last decade. Individual participation in clinical research broadened, with an increase in diverse populations, diseases, and geographic settings. The successful execution of these studies, however, has been compromised by an international shortage of clinical research professionals, coupled with an appreciation of the growing number of core competencies necessary for performance. Developed over a decade ago, the Joint Task Force for Clinical Trial Competency (JTF) Framework outlines the knowledge, skills and attitudes that are essential for the safe and effective conduct of a clinical study. This framework has been used to develop professional pathways, trainings, and certification programs and has been extended internationally through translation. |
| clinical project management courses: Principles and Practice of Clinical Trial Medicine Richard Chin, Bruce Y Lee, 2008-07-25 Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. - Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data - Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine - Expert authorship whose experience includes running clinical trials in an academic as well as industry settings - Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy |
| clinical project management courses: Project Management for Healthcare Information Technology Scott Coplan, David Masuda, 2011-01-26 A Proven, Integrated Healthcare Information Technology Management Solution Co-written by a certified Project Management Professional and an M.D., Project Management for Healthcare Information Technology presents an effective methodology that encompasses standards and best practices from project management, information technology management, and change management for a streamlined transition to digital medicine. Each management discipline is examined in detail and defined as a set of knowledge areas. The book then describes the core processes that take place within each knowledge area in the initiating, planning, executing, controlling, and closing stages of a project. Real-world examples from healthcare information technology project leaders identify how the integrated approach presented in this book leads to successful project implementations. Coverage Includes: Integrating project, information technology, and change management methodologies PMBOK Guide process groups--initiating, planning, executing, controlling, and closing Project management knowledge areas--integration, scope, time, cost, quality, human resource, communication, risk, and procurement management IT management knowledge areas--user requirements, infrastructure, conversion, software configuration, workflow, security, interface, testing, cutover, and support management Change management knowledge areas--realization, sponsorship, transformation, training, and optimization management |
| clinical project management courses: Leadership Competencies Of A Clinical Trial Project Manager John Petrera, 2024-06-17 Leadership competencies of a clinical trial project manager is unique in that this qualitative inquiry research project not only explores the specific top leadership competencies of project managers involved in pharmaceutical clinical trials, but the concepts reviewed in this book are applicable broad spectrum to multiple professional fields. The proposed leadership framework combines elements of leadership competencies, project management competencies, personal competencies, and includes a review of the leadership types from the traits theory of leadership. The leadership concepts described are universal and can be applied to improve any leader's abilities. While this book focuses on clinical trial project managers, the concepts and best practices apply to all PMs within pharmaceuticals or in any other field. The derived PM competency framework is transferrable to PMs in numerous industries and may also provide applicable guidance to others, regardless of their profession. Ultimately, the expansion of the PM triangle is a useful concept that many will find interesting. Additionally, personal competencies can improve personal effectiveness, achievements, and actions. This project identified 5 themes to include (a) CTPM experience and knowledge, (b) leadership competencies, (c) leadership types (styles), (d) personal competencies, and (e) project management competency development (PMCD). The 5 themes identified are all critical to understanding the perspectives obtained from the study participants regarding leadership competencies to maximize efficiencies of research and development. The results of this study can (a) potentially assist new CTPMs, (b) provide a refresher for CTPMs seeking improvement, (c) provide support for project managers in general, and (d) may assist hiring managers in determining the leadership skills to seek. The results from this study may support the project, program, and portfolio managers from various industries to better understand the leadership competencies and the overall framework that support project management. At the same time, these 5 themes, interpreted in the broadest terms, may be helpful to you! |
| clinical project management courses: How to Get a Job and Manage Your Career in Clinical Research Martin Robinson, 2009-06 |
| clinical project management courses: Understanding Clinical Research Renato D. Lopes, Robert A. Harrington, 2013-05-22 A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials |
| clinical project management courses: Project Management for Healthcare Informatics Susan Houston, Lisa Anne Bove, 2007-11-25 Through its use of real clinical examples, this book provides an explanation of the project management process tailored for nurses. It first describes, in detail, the project management process along with its relationship to the phases of the project life cycle. Coverage includes the tools available to successfully complete each phase of the project management process and advance the project life cycle. With the aid of case studies and project examples, the book then examines how to apply these principles in the day-to-day work of the nurse, whether manager, staff nurse, educator, researcher, or informatician. |
| clinical project management courses: The Clinical Research Process in the Pharmaceutical Industry Gary M. Matoren, 2020-08-18 This book examines the sequence of events and methodology in the industrial clinical research process; a reference for multidisciplinary personnel. It is the conceptual framework involving the philosophical, economic, political, historical, regulatory, planning, and marketing aspects of the process. |
| clinical project management courses: Pharmaceutical Project Management Anthony Kennedy, 2008-03-17 Encompassing the full spectrum of project management's role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration |
| clinical project management courses: Research Project Management and Leadership P. Alison Paprica, 2024-01-31 The project management approaches, which are used by millions of people internationally, are often too detailed or constraining to be applied to research. In this handbook, project management expert P. Alison Paprica presents guidance specifically developed to help with the planning, management, and leadership of research. Research Project Management and Leadership provides simplified versions of globally utilized project management tools, such as the work breakdown structure to visualize scope, and offers guidance on processes, including a five-step process to identify and respond to risks. The complementary leadership guidance in the handbook is presented in the form of interview write-ups with 19 Canadian and international research leaders, each of whom describes a situation where leadership skills were important, how they responded, and what they learned. The accessible language and practical guidance in the handbook make it a valuable resource for everyone from principal investigators leading multimillion-dollar projects to graduate students planning their thesis research. The book aims to help readers understand which management and leadership tools, processes, and practices are helpful in different circumstances, and how to implement them in research settings. |
| clinical project management courses: Fundamentals of Clinical Research Antonella Bacchieri, Giovanni Della Cioppa, 2007-04-29 Here is a new book on methods and issues in clinical research. Its objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research. The book ends with a brief description of the drug development process and the phases of clinical development. |
| clinical project management courses: Project Management for the Pharmaceutical Industry Mr Tony Grundy, Ms Laura Brown, 2012-09-28 The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management. |
| clinical project management courses: Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries Pete Harpum, 2011-09-20 This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years. |
| clinical project management courses: Project Management for Drug Developers Joseph P. Stalder, 2022-12-29 Project managers in drug development are the driving force behind the coordination of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the PM will need to work closely with, and essential tools of the trade including frequently used techniques and methodologies. This book is useful for both entry-level and advanced-level PMs, as well as non-project managers from other functions. Features Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development. Provides the most up-to-date and best practices, techniques, and methodologies in project management. Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process. Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics. Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses. |
| clinical project management courses: Clinical Trial Registries MaryAnn Foote, 2006-11-09 ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects. Not only does this book discuss the genesis of these requirements, it also provides practical information for researchers and sponsors on how to establish a workflow for a clinical registry project, how to file to a registry, and how to post results. |
| clinical project management courses: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. |
| clinical project management courses: Project Management in Nursing Informatics Mary Joy Garcia-Dia, DNP, RN, 2019-02-20 “This book provides an important roadmap to assist nursing professionals, indeed all healthcare professionals, to achieving maximum benefits in patient care delivery through the application of technology and information science to clinical care.” -Joyce J. Fitzpatrick, PhD, MBA, RN FAAN Elizabeth Brooks Ford Professor Nursing Frances Payne Bolton School of Nursing Case Western Reserve University Data and technology factor more heavily than ever on quality patient care in today’s healthcare system. As technology increases in complexity and scope, involving more healthcare roles and types of data analysis, so does the demand for project management and astute leadership. Among other responsibilities, Nurse Informatics Specialists (NIS) manage and implement technology initiatives so clinicians’ workflow is more efficient, which improves patient care, and the bottom line. To accomplish these goals, it is essential that the NIS has excellent Project Management skills. Written for graduate nursing students, Project Management in Nursing Informatics provides core project management skills for Informatics students. This text gives students project management examples using realistic healthcare case scenarios. Chapters describe nursing informatics competencies and project management concepts that will be essential for clinical practicum and practical experience. Case scenarios show the consequences of right and wrong processes and highlight factors that lead to success. With plenty of chapter activities, exercises, and tasks, this text pushes the written concepts into practical realities for the NIS. Key Features Incorporates key concepts in defining scope, tracking budget, and meeting deliverables within the expected timeline Features cases with real-world scenarios Contains templates to monitor and track multiple projects Provides tools to manage, track, and complete a capstone project Presents a basic review of key nursing informatics competencies and its relationship in designing a capstone project Workflow analysis, concept mapping, data specification, collection and analysis Accompanied by Instructor’s PowerPoints |
| clinical project management courses: Expert Judgment in Project Management Paul S. Szwed, 2016-04-01 Expert judgment is a major source of information that can provide vital input to project managers, who must ensure that projects are completed successfully, on time, and on budget. Too often, however, companies lack detailed processes for finding and consulting with experts—making it hard to match the required know-how with the project at hand. In Expert Judgment in Project Management: Narrowing the Theory-Practice Gap, Paul S. Szwed provides research that will help project managers become more adept at using expert judgment effectively. |
| clinical project management courses: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt Furberg, David L. DeMets, 1998 This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors. |
| clinical project management courses: Research Management Jan Andersen, Kristel Toom, Susi Poli, Pamela F. Miller, 2017-11-15 Research Management: Europe and Beyond addresses the myriad responsibilities related to research management and administration. The book incorporates narratives from those working in the field to provide insight into the profession. The book also offers a unique perspective on the topic by incorporating global perspectives to address the growing interdisciplinary nature of research collaboration. The book outlines practical advice for those in the research management and administration profession at all levels of experience. It is also a useful tool that research institutions and research groups can use to assist in planning and streamlining their research support. - Offers a deeper understanding of the research management and administrative landscape through single and collective definitions and experiences - Provides an overview of the research environment and explores the international research arena - Discusses some of the most complex issues in research management and administration by covering topics such as ethics, innovation, research impact, organizational structures, and processes for the project life cycle |
| clinical project management courses: Design Methods and Practices for Research of Project Management Beverly Pasian, Rodney Turner, 2016-08-12 Design Methods and Practices for Research of Project Management is the most comprehensive guide on how to do research of and in project management. Project management as a discipline has experienced near-exponential growth in its application across the business and not-for-profit sectors. This second edition of the authoritative reference book offers a substantial update on the first edition with over 60% new content and so provides both practitioner and student researchers with a fully up-to-date and complete guide to research practice on project management. In Design Methods and Practices for Research of Project Management, Beverly Pasian and Rodney Turner have brought together 27 original chapters from many of the leading international thinkers in project management research. The collection looks at each step in the research stages, including research strategy, management, methodology (quantitative and qualitative), techniques as well as how to share and publish research findings. The chapters offer an international perspective with examples from a wide range of project management applications; engineering, construction, mega-projects, high-risk environments and social transformation. Each chapter includes tips and exercises for the research student, as well as a complete set of further references. The book is the go-to text for practitioners undertaking research in companies, and also doctoral and masters students and their supervisors who are involved in research projects in and for universities. |
| clinical project management courses: Responsible Conduct of Research Adil E. Shamoo, David B. Resnik, 2009-02-12 Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today. |
| clinical project management courses: The Oxford Handbook of Project Management Peter W. G. Morris, Jeffrey K. Pinto, Jonas Söderlund, 2012-07-19 The Oxford Handbook of Project Management presents and discusses leading ideas in the management of projects. Positioning project management as a domain much broader and more strategic than simply 'execution management', this Handbook draws on the insights of over 40 scholars to chart the development of the subject over the last 50 years or more as an area of increasing practical and academic interest. It suggests we could be entering an emerging 'third wave' of analysis and interpretation following its early technical and operational beginnings and the subsequent shift to a focus on projects and their management. Topics dealt with include: the historical evolution of the subject; its theoretical base; professionalism; business and societal context; strategy; organization; governance; innovation; overruns; risk; information management; procurement; relationships and trust; knowledge management; practice and teams. This handbook is of particular relevance to those interested in the research issues underlying project management. |
| clinical project management courses: Advanced Project Portfolio Management and the PMO Gerald I. Kendall, Steven C. Rollins, 2003-04-15 Advanced Project Portfolio Management is a comprehensive book which presents a roadmap for the achievement of high value enterprise strategies and superior project management results. It provides methods for best project selection, faster completion, optimal project portfolio management, and how to explicitly measure the PMO for rapidly increasing project ROI. |
| clinical project management courses: Global Clinical Trials Playbook Menghis Bairu, Richard Chin, 2012-06-12 Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in neglected diseases and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. - Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world - Provides real world international examples which illustrate the practical translation of principles - Includes forms, templates, and additional references for standardization in a number of global scenarios |
| clinical project management courses: How to Prepare for Interviews and Develop your Career Carol Forde-Johnston, 2020-04-02 How to Prepare for Interviews and Develop Your Career is packed with practical advice and guidance to help nurses and midwives fulfil their career aspirations. The book is ideal for newly and recently qualified nurses and midwives and will also be suitable for students making the transition to NQN. Guidance, key tips and case examples are organised in seven steps that help provide the key to positive career development: Identify your career options Drive your own career development Support others and influence change Complete a strong application and personal statement Prepare for interviews by creating an interview plan Deal positively with challenges Make your achievements stand out Carol Forde-Johnston is Recruitment and Retention Lead in a large NHS Trust and has more than 30 years’ experience as a Registered Nurse and University Lecturer Practitioner. She has drawn on all that experience to write an accessible and practical book that address the questions and concerns frequently raised by students and healthcare professionals – and to help you develop your career as a nurse or midwife. |
| clinical project management courses: Drug and Biological Development Ronald Evens, 2007-08-18 This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines. |
| clinical project management courses: Outsourcing Clinical Research Projects David Bryde, 2007 This book discusses the decision-making process of out-sourcing and provides a model of the process. It covers topics associated with finding an appropriate Clinical Research Organisation, including: the feasibility process, types of contracts, legal documentation and the working relationship between client and sub-contractor. |
| clinical project management courses: Project Management for Healthcare David Shirley, 2011-04-25 As a growing number of healthcare organizations implement project management principles to improve cost and service efficiencies, they are in desperate need of resources that illustrate the project management needs of today’s healthcare professional. Project Management for Healthcare fills this need. Using easy-to-follow language, it explains how the time-tested principles of project management can help maximize limited resources and ensure the highest possible quality of care. Exploring the discipline of project management from the perspective of the healthcare environment, the book dissects the project process and provides the tools and techniques required to successfully plan, execute, and control any healthcare-based project. From identifying stakeholders to constructing a project plan, it covers the spectrum of project planning activities. Complete with chapter summaries, exercises, hints, review questions, and case studies, it illustrates applications across a range of healthcare settings. Explains how to utilize the project plan to execute projects within budget, schedule, and quality objectives Covers program management as it relates to healthcare Addresses the interaction between healthcare and information technology Presents best practices from the pharmaceutical and medical equipment industries—that can easily be adapted to any healthcare setting Because most healthcare personnel will inevitably have to work with program management and need to interact with pharmaceutical companies and medical device manufacturers, the book provides an inside look at the processes and best practices used to bring products to market in these industries. Explaining how to adapt these processes to drive down costs and improve the quality of care in any healthcare setting, the book includes a case study of a medical facility that illustrates the proper application of the tools and techniques needed to manage healthcare projects effectively and efficiently. |
| clinical project management courses: School of Nursing University of California, San Francisco. School of Nursing, 2000 |
| clinical project management courses: Developing a Successful Clinical Research Program Cara East, 2018-08-08 This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit. Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field. Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting. |
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
