Prepare for your next role in clinical research.
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Gain a comprehensive understanding of project management principles, including project phases, success criteria, and the use of various project management tools.
Develop expertise in stakeholder management, identifying key stakeholders, and employing effective communication strategies tailored to different stakeholder needs.
Master the skills required for project risk management, including risk identification, analysis, quantification, and the implementation of risk mitigation strategies.
Acquire practical knowledge in clinical project management, such as developing clinical risk management plans, maintaining regulatory compliance, and managing audits and inspections.
This comprehensive module is designed to equip you with the essential skills needed to effectively close and evaluate clinical research projects. You’ll gain in-depth knowledge on avoiding project drift, setting completion criteria, leading close-out meetings, and conducting thorough post-project evaluations. By mastering these aspects, you’ll ensure that your projects are completed successfully and yield valuable insights for future research endeavors.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Avoid project drift by proper planning, strong management, and clear communication.
✓ Set project completion criteria and produce an adequate Project Acceptance Checklist.
✓ Lead the close-out meeting with confidence and precision.
✓ Evaluate the project – understand what went well, what went wrong, and derive lessons learnt.
KAMILA NOVAK
25+ years experience
This module will equip you with the skills to identify, analyze, and effectively communicate with stakeholders. You will learn how to tailor your communication strategies to different stakeholder needs, ensuring successful project outcomes.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the stakeholder landscape.
✓ Analyze stakeholders effectively.
✓ Identify key stakeholders.
✓ Communicate successfully with different stakeholders, choosing the appropriate style, frequency, and level of detail.
KAMILA NOVAK
25+ years experience
You’ll dive into the strategic alignment of projects, the intricacies of project start-up, and the critical role of decision-making in project success. Learn to craft a comprehensive project definition that ensures clarity and stakeholder alignment from the outset.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the project external and internal environment.
✓ Assess how the environmental factors affect the project.
✓ Define requirements to make the project a success story.
✓ Outline the project scope.
✓ Build a strong project definition.
✓ Obtain approval for your project definition.
KAMILA NOVAK
25+ years experience
In this module, you will delve into the essentials of managing risks within clinical research projects. Gain a comprehensive understanding of risk management processes, learn to identify potential risks, and develop strategies to mitigate them effectively. Through this module, you will enhance your ability to ensure project success by proactively managing uncertainties and improving overall project outcomes.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand what constitutes a risk and the terminology used in risk management.
✓ Learn the risk management process and an overview of various tools.
✓ Identify project risks using a starter checklist.
✓ Develop a primary response strategy for risks.
✓ Analyze and quantify risks, calculating the Risk Priority Number.
✓ Monitor risks under different conditions.
✓ Assess the effectiveness of your risk management process.
✓ Draw lessons for process improvements.
KAMILA NOVAK
25+ years experience
This module will equip you with essential knowledge and skills to manage risks effectively in clinical research. You’ll delve into the regulatory framework, learn to apply risk management principles, and develop comprehensive risk management plans. Gain proficiency in using advanced tools and technology to mitigate risks, ensuring the success of clinical studies.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the regulatory framework for risk management in clinical studies.
✓ Apply general risk management principles and procedures on clinical projects.
✓ Develop the Clinical Risk Management Plan.
✓ Use adequate tools to manage clinical study risks efficiently.
✓ Communicate effectively with functional teams to manage clinical study risks successfully.
KAMILA NOVAK
25+ years experience
In this module, you’ll gain essential skills to manage crises in clinical research settings. Learn to identify potential risks, effectively lead through crises, and turn challenging situations into opportunities for improvement. This comprehensive module covers everything from crisis definition to real-world examples of crisis management.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview
✓ Understand different situations and decide on appropriate management approaches.
✓ Anticipate critical situations that may occur and their impact on the project.
✓ Learn what it takes to lead through a crisis successfully – gain insights from the successes and mistakes of others.
✓ See crisis as an opportunity for improvement.
KAMILA NOVAK
25+ years experience
This module equips you with the essential skills for project planning in clinical research. You’ll delve into the key stages of planning, identify critical gaps, and allocate responsibilities to ensure the successful delivery of your clinical studies. Mastering project planning is crucial for effective study execution, compliance, and budgeting.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Identify the key stages of a project.
✓ Analyze gaps for a successful delivery.
✓ Plan strategies to bridge the gaps.
✓ Assign responsibilities to your team members.
✓ Develop a clinical study budget.
KAMILA NOVAK
25+ years experience
This module is designed to equip you with the skills necessary to create and manage a detailed project plan. You’ll learn how to identify the critical path, allocate resources efficiently, and optimize your project schedule to ensure timely and successful project completion. By the end of this module, you’ll be able to prepare a realistic baseline schedule and use it effectively during the project execution phase.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Prepare a detailed realistic plan (baseline schedule) of the project including milestones, critical path, work breakdown, and allocated resources.
✓ Use a well-designed baseline schedule to measure progress and manage the project in the execution phase.
✓ Analyze resource requirements and optimize schedules to ensure project success.
✓ Review the project risk log and budget to maintain project integrity.
✓ Seek approval to launch your project with confidence.
KAMILA NOVAK
25+ years experience
This module focuses on equipping you with the skills and knowledge necessary to effectively launch and execute clinical research projects. You’ll learn to manage project timelines, monitor progress, and ensure compliance with regulatory standards. With an emphasis on precision and professionalism, this module prepares you to handle the complexities of clinical research project management.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Prepare for project execution with thorough planning and organization.
✓ Monitor progress using trend analysis and ANOVA.
✓ Manage risks and protocol deviations effectively.
✓ Control costs and ensure project stays within scope.
✓ Perform quality assurance and quality control audits.
✓ Handle audits and inspections with confidence.
✓ Manage CAPA plans efficiently.
✓ Support CSR development and ensure timely completion.
KAMILA NOVAK
25+ years experience
This module focuses on equipping you with the skills and knowledge necessary to effectively launch and execute clinical research projects. You’ll learn to manage project timelines, monitor progress, and ensure compliance with regulatory standards. With an emphasis on precision and professionalism, this module prepares you to handle the complexities of clinical research project management.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Prepare for project execution with thorough planning and organization.
✓ Monitor progress using trend analysis and ANOVA.
✓ Manage risks and protocol deviations effectively.
✓ Control costs and ensure project stays within scope.
✓ Perform quality assurance and quality control audits.
✓ Handle audits and inspections with confidence.
✓ Manage CAPA plans efficiently.
✓ Support CSR development and ensure timely completion.
KAMILA NOVAK
25+ years experience
This exam will help you apply your newly acquired knowledge and skills, covering a wide range of topics from the certificate program to ensure your readiness for a position in clinical research.
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Yes. After the 10 modules you take the online VIARES certification exam: 100 questions in 90 minutes, pass mark 80 %, with two attempts included (the higher score counts). When you pass, you receive your VIARES course certificate, signed by CEO Dietmar Eglhofer. Every VIARES certificate can be verified publicly by its code on the VIARES certificate verification page, downloaded as a PDF and shared on LinkedIn. On enrollment you also receive a Confirmation of Enrollment.
The clinical research project management course comprises 150 hours of learning and runs fully online and self-paced. There is no fixed schedule, so you can complete it next to a full-time job or in a focused effort. Each of the 10 modules follows the same steps:
This clinical trial project management training is aimed at clinical research professionals – for example clinical research associates (CRAs) or data managers – who want to move into project management. On successful completion you will have the knowledge, skills and competencies to start as a Clinical Project Manager, Study Lead or in a similar role. The course also explains how the project manager role differs between a CRO and a sponsor.
A clinical project manager plans and steers a clinical trial from start-up to close-out: defining scope and success criteria, building the timeline and critical path, developing and tracking the study budget, coordinating cross-functional teams such as CRAs, data managers and statisticians, managing risks and stakeholders, and keeping the study in line with GCP and regulatory requirements. Read more in our article on what a clinical research project manager does.
All 10 modules are led by expert instructor Kamila A. Novak, MSc, who brings more than 25 years of experience. VIARES was founded in 2018 and has trained 12,000+ learners from 120+ countries.
Advanced Training Modules + VIARES Study Guide + Certification Exams. Lifetime Access to Unmatched Curriculum:
Original price was: € 199,90.€ 99,90Current price is: € 99,90.
Online Self-paced
learn at your own schedule and pace
IAOCR-accredited (2018), industry-recognized certification with a practitioner-built curriculum. Seminars, assignments and exams tailored to your need to stay ahead and stand out for the new job role! 100% Money-back Guarantee with 5 Day Refund Policy.
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We pride ourselves on high-quality programs. That’s why we offer a 5-day no-questions-asked 100% money-back guarantee. If for any reason you are unhappy, you will get a full refund.
Your membership to VIARES includes everything you need to excel in your clinical research career.
Connect with peers worldwide to share insights, best practices, and engage in thought-provoking discussions.
Redefine your career trajectory and fast-track your personal growth with powerful career mapping and feedback tools.
Develop the latest and most in-demand clinical research skills with 100% online, industry-recognized courses.
VIARES is known by the world’s leading organizations for clinical research providing you with the best training for your future dream job!
With VIARES you also get support with finding your clinical research dream job.
VIARES’ digital certificates are a proven way to showcase that you mastered a new skill and upgrade your resume to land your next dream job.
Clinical Research Project Manager
Verified ownerVery clear and easy to follow tutorials
Verified ownerno help available
Verified ownerHighly recommend the TMF Specialist Certification!I recently completed the Trial Master File Specialist Certification through VIARES Academy, and it exceeded my expectations. The course structure is incredibly clear and well-paced, breaking down complex regulatory standards, compliance metrics, and document management rules into practical, real-world examples. The training is highly practical, up to date with global industry standards, and easy to follow. The self-paced modules and assignments truly prepare you for the current clinical research job market. I feel completely confident moving forward in my clinical operations career. Thank you, VIARES!
Verified ownerwonderful
Verified ownerI am very satisfied with the course.Best money investment, especially for the beginners as me.
Verified ownerEducative indeed
Verified ownerI highly recommend this All-in-One Clinical Research course to anyone who wants to start or develop a career in clinical trials. The course is very well structured, easy to follow, and covers a wide range of important topics, including Clinical Trial Assistant responsibilities, Study Start-Up, Trial Master File (TMF), Clinical Trial Management, GCP principles, communication skills, regulatory requirements, and many practical examples from the industry.
What I appreciated most is that the instructors explain complex concepts in a clear and practical way, making the content suitable even for beginners while still providing valuable insights for professionals with previous healthcare experience.
Thanks to this training, I feel much more confident for interviews and much better prepared to begin my career in Clinical Operations. The knowledge is directly applicable to real-world clinical research, and the materials can be revisited whenever needed.
If you are serious about entering the clinical research industry, this course is definitely a worthwhile investment. Thank you to the Viares Academy team for creating such a comprehensive and high-quality learning experience.
Verified ownerThank you very much for the updated information on the ICG GCP E6 (R3) on your website. Quality information at a very nominal cost.
Verified ownerThe minicourses on all the listed topics were very useful to my students and me.
