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Clinical Research Project Manager – Enterprise

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.

COURSE Content

 Successfully complete the 9 competency modules below to obtain your VIARES Clinical Research Project Manager Certificate.
  • Get familiar with project management terminology.
  • Define project success criteria.
  • Set up project phases correctly.
  • Choose fitting tools to manage a project.
  • Communicate efficiently while managing a project.
  • Understand typical differences between the PM’s role depending on the company type.
  • Understand the stakeholder landscape.
  • Analyse stakeholders.
  • Identify key stakeholders.
  • Communicate successfully with different stakeholders choosing adequate style, frequency, and the level of detail.
  • Understand the project external and internal environment.
  • Assess how the environmental factors affect the project.
  • Define requirements to make the project a success story.
  • Define the project scope.
  • Build a strong project definition.
  • Obtain the approval for your project definition.
  • Differentiate risks, constraints, and issues.
  • Identify project risks and decide on a suitable primary response strategy.
  • Analyse project risks in three dimensions – likelihood, impact, and detectability.
  • Quantify risks and calculate the Risk Priority Number.
  • Optimise conditions for high risks.
  • Monitor risks and keep them under control.
  • Assess the effectiveness of your risk management process.
  • 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.
  • Identify key stages of a project.
  • Analyse whether something is missing for a successful delivery (gaps).
  • Plan how to bridge the gaps.
  • Assign responsibilities to your team members.
  • Develop the clinical study budget.
  • 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.
  • Monitor study progress.
  • Identify early signs of the project falling behind or going astray compared to the plan.
  • Apply measures to keep the project on track.
  • Apply measures to maintain GCP and regulatory compliance.
  • Control study costs and handle out-of-scope requests.
  • Manage and support your team during audits and inspections.
  • Manage CAPA plans effectively and efficiently.
  • Contribute to the timely development of the CSR.
  • 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.
  • Evaluate the project – what went well, what went wrong and why, derive lessons learnt.

VIARES CERTIFICATE

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.

Getting a clinical project manager certificate can provide you with several benefits, including:

  • Enhanced skills and knowledge: A clinical project manager certificate program can provide you with the skills and knowledge needed to effectively manage clinical trials, including project planning, regulatory compliance, risk management, and team coordination. You can gain expertise in the latest regulations and trends in the field, and stay up-to-date with the latest industry best practices.
  • Career advancement: A clinical project manager certificate can enhance your resume and demonstrate to potential employers that you have the knowledge and skills required for a clinical project manager position. It can also help you stand out in a competitive job market and increase your chances of career advancement.
  • Industry recognition: A clinical project manager certificate can provide additional credibility and recognition in the field.
 

Overall, getting a clinical project manager certificate can provide you with a valuable credential, enhanced skills and knowledge, and opportunities for career advancement and networking in the clinical research field.

Hear from our graduates

Matthew

As someone who has no monitoring experience, the CRA Academy made it easy for me to understand how the Clinical Research field works. The instructors are easy to understand and they accommodate all queries that we have.

Matea

I am really happy that I joined the VIARES CRA Academy, it was an amazing experience filled with valuable information, personal insights from the professionals, and really interesting topics. I am very satisfied with the overall structure of the

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program and would definitely recommend it!

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WHY BECOME A Clinical Project Manager?

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.

WHAT ARE TYPICAL RESPONSIBILITIES OF A Clinical Project Manager?

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.

IS THIS THE BEST OPTION FOR ME?

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.

Description

A Flexible Online Setup

You can start the training right away and complete it at your own pace. This training contains 150 hours of online material.
You do not need to wait for a kick-off date, you can start your training anytime  – as early as today if you wish.

Get Certified & Job Ready

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 Research Project Manager or similar.

The VIARES Clinical Research Project Manager program is more than just a training. It’s a life-changer!

Certificates:

  • VIARES

 

Life-time payment plan includes:

  • all benefits from the monthly payment plan with only one payment
  • PLUS – unlimited life-time access to your training course
  • PLUS – free download of your training course handouts for offline learning
 

Monthly payment plan includes:

  • registration fee
  • all online-training course material
  • online access to our learning management system
  • mini-exams during the training to test your knowledge
  • VIARES exam – 2 attempts included
  • personalized certificate upon completion
  • join career events at no cost
  • free access to our weekly updated global job list
  • apply to exclusive job offers
  • get your personal career coaching
  • any time free cancellation of monthly payment

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12 SMALL INSTALLMENTS paid monthly over one year
  • One year access to your training courses
  • Personalized certificate upon completion
  • VIARES exam – 2 attempts included
  • All online-training course material
  • Online access to our learning management system

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  • One year access to your training courses​
  • Personalized certificate upon completion
  • VIARES exam – 2 attempts included​
  • All online-training course material
  • Online access to our learning management system
  • Including the VIAES CAREER ACCELERATOR
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  • No training course handouts for offline learning
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