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Clinical Research Project Manager Academy

On successful completion of this program, you will be certified and will have acquired knowledge, skills and competencies to start at an entry level role as Clinical Project Manager or similar.

What you will learn

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.

Why VIARES?

✓ Globally accredited & industry recognized
✓ Join 9,000+ members worldwide
✓ Making you the best candidate for the job
✓ All the tools you need to level up your career

Program structure

Project Management BasicsEXPERT
1 lesson • 1 assignment • 1 knowledge check • 10 hours

ENSURE SUCCESSFUL PROJECT COMPLETION

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.

Your instructor:

KAMILA NOVAK

25+ years experience 

Understanding and managing stakeholders is crucial in clinical research

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.

Your instructor:

KAMILA NOVAK

25+ years experience 

essential skills to conceive and define successful projects

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.

Your instructor:

KAMILA NOVAK

25+ years experience 

MASTER THE ART OF PROJECT RISK MANAGEMENT

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.

Your instructor:

KAMILA NOVAK

25+ years experience 

BUILD YOUR EXPERTISE IN CLINICAL RISK MANAGEMENT

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.

Your instructor:

KAMILA NOVAK

25+ years experience 

MASTER CRISIS MANAGEMENT IN CLINICAL RESEARCH

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.

Your instructor:

KAMILA NOVAK

25+ years experience 

PLAN YOUR CLINICAL RESEARCH PROJECTS EFFECTIVELY

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.

Your instructor:

KAMILA NOVAK

25+ years experience 

MASTER PROJECT SCHEDULING AND MANAGEMENT

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.

Your instructor:

KAMILA NOVAK

25+ years experience 

effectively launch and execute clinical research projects

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.

Your instructor:

KAMILA NOVAK

25+ years experience 

effectively launch and execute clinical research projects

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.

Your instructor:

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.

Explore the full curriculum in pdf and receive email reminders when enrollment closes:

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Online Self-paced
learn at your own schedule and pace

Duration: 150 hours
Study 3 hours a week to finish in 12 months
10 modules + official certificate
testing through quizzes + exams

Get free access to our learning portal and experience it yourself

You can test your knowledge with our free micro-certificates, that cover some of the most important topics in clinical research.
This way you can test the learning environment before buying!

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1 Year Access
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12 months access to the Clinical Research Project Manager Academy course
Original price was: € 49,90.Current price is: € 9,90. / month for 12 months

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12 months access to the Clinical Research Project Manager Academy course at a discounted price
Original price was: € 199,90.Current price is: € 99,90.

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Life-time access to the Clinical Research Project Manager Academy course
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What VIARES members get

Your membership to VIARES includes everything you need to excel in your clinical research career.

Worldwide LinkedIn community

Connect with peers worldwide to share insights, best practices, and engage in thought-provoking discussions.

Comprehensive Resource Library

Access a vast collection of templates, tools, and playbooks to enhance your clinical research work.

Career center

Redefine your career trajectory and fast-track your personal growth with powerful career mapping and feedback tools.

Easy Learning Portal

Enjoy a user-friendly platform that makes accessing course materials and resources straightforward and convenient.

Accredited Courses

Develop the latest and most in-demand clinical research skills with 100% online and globally recognized courses.

 

VIARES is known by the world’s leading organizations for for clinical reasearch providing you with the best training for your future dream job!

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With VIARES you also get support with finding your clinical research dream job.

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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.

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FAQ

Need help making the right choice?

Send our admissions advisors a message.

There are several reasons why you might consider becoming a clinical project manager. Here are a few:

  • Contributing to medical advancements: As a clinical project manager, you would be responsible for overseeing the planning, implementation, and monitoring of clinical trials, which are a critical step in the development of new medical treatments and therapies. By playing a key role in the successful completion of clinical trials, you would be contributing to important medical advancements that could improve the lives of many people.
  • Variety of work: Clinical project managers work with a diverse range of stakeholders, including scientists, physicians, regulatory authorities, and patients. This can provide a stimulating and varied work environment that requires a mix of technical and interpersonal skills.
  • Career growth: Clinical project management is a growing field, and there are many opportunities for career growth and advancement. As you gain experience and expertise, you may be able to take on more senior roles or move into related areas, such as clinical operations, medical affairs, or regulatory affairs.
  • Competitive compensation: Clinical project management is a highly skilled and specialized role, and as such, it tends to offer competitive compensation and benefits packages.

 

Finally, many clinical project managers find their work personally rewarding, knowing that they are contributing to the development of important medical treatments and therapies that can improve the lives of patients.

The responsibilities of a clinical project manager can vary depending on the specific organization, project, and phase of the clinical trial. However, in general, a clinical project manager is responsible for overseeing the planning, implementation, and monitoring of clinical trials in accordance with regulatory requirements and company policies. Here are some typical responsibilities of a clinical project manager:

  • Develop and manage project plans: This includes defining the scope of the project, developing timelines, and ensuring that all project deliverables are completed on time and within budget.
  • Coordinate cross-functional teams: Clinical trials often involve multiple departments and stakeholders, including clinical research associates, data managers, and statisticians. The clinical project manager is responsible for ensuring effective communication and collaboration between all team members.
  • Ensure regulatory compliance: Clinical trials are subject to numerous regulations and guidelines, and the clinical project manager is responsible for ensuring that all activities are conducted in compliance with these requirements.
  • Manage study budget: The clinical project manager is responsible for managing the budget for the clinical trial, ensuring that all expenses are accounted for and that the trial is conducted within the allocated budget.
  • Identify and mitigate risks: The clinical project manager is responsible for identifying potential risks to the clinical trial and developing strategies to mitigate them.
  • Monitor and report on study progress: The clinical project manager is responsible for monitoring the progress of the study and providing regular updates to stakeholders on study status and performance metrics.
  • Manage study documents: Clinical trials generate a large volume of documentation, and the clinical project manager is responsible for ensuring that all study documents are complete, accurate, and up-to-date.
  • Manage study timelines: The clinical project manager is responsible for ensuring that all study activities are conducted according to the pre-defined timelines and that any delays or issues are addressed in a timely manner.

 

Overall, the clinical project manager plays a critical role in the success of a clinical trial, ensuring that all activities are conducted in compliance with regulatory requirements and that the trial is completed on time and within budget.

Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the course and your exam, you get your personal “Course Certificate” including:

  • course title
  • contact hours
  • continuing education units (CEU)
  • your overall course score
  • date of completion
  • personal certificate verification code
 

We also show you how to best share your certificate on LinkedIn and other social media platforms.

There are several reasons why you might consider getting a CRA certification:

Demonstrated knowledge and commitment: Obtaining a CRA certification demonstrates to employers and colleagues that you have a strong understanding of clinical research processes, regulations, and best practices. It shows your commitment to your career in clinical research and can set you apart from other candidates when applying for jobs.

Increased job opportunities: Many employers prefer or require candidates with CRA certifications for their open positions. Having a certification can make you a more competitive candidate and increase your job opportunities.

Career advancement: A CRA certification can help you advance in your career by opening up opportunities for promotion, leadership roles, and increased pay.

Continuing education: Many employers require ongoing education and professional development, which can help you stay up-to-date with the latest developments in the field.

Overall, obtaining a CRA certification can help you stand out in a competitive job market, demonstrate your knowledge and commitment to your career, and open up opportunities for career advancement and professional development.

No, you can proceed with the course in your own pace. But please keep in mind, that you might have to purchase a course extension in order to continue learning (check the pricing table above).

To become a clinical project manager, you typically need a combination of education, training, and experience in the clinical research field. Here are some key background requirements:

  • Education: A bachelor’s degree in a science-related field, such as biology, pharmacology, or a related field is typically required. A master’s degree in a related field can be an advantage.
  • Experience: Experience in clinical research is highly valued in a clinical project manager role. Individuals with experience as clinical research associates (CRAs), data managers, or other clinical research roles are often considered strong candidates for clinical project manager positions.
  • Knowledge of regulations: Clinical project managers must have a solid understanding of Good Clinical Practice (GCP) guidelines and other regulatory requirements for clinical trials.
  • Project management skills: Clinical project managers should have experience in managing complex projects, including planning, executing, and monitoring project activities. They should also have strong organizational skills and be able to prioritize and manage multiple tasks simultaneously.
  • Communication skills: Clinical project managers must have excellent communication skills, as they need to work with a wide range of stakeholders, including sponsors, investigators, and regulatory authorities.
  • Attention to detail: Clinical trials involve a large volume of data and documentation, and clinical project managers must have strong attention to detail to ensure that all study documents and data are accurate and complete.

 

Overall, a combination of education, training, and experience in clinical research, along with strong project management, communication, and organizational skills, are essential for a career as a clinical project manager.

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