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.

Project Management Basics

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.

Stakeholder Management

Understand the stakeholder landscape.
Analyse stakeholders.
Identify key stakeholders.
Communicate successfully with different stakeholders choosing adequate style, frequency, and the level of detail.

Project Conception and Definition

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.

Project Risk Management

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.

Clinical Risk Management

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.

Project Planning

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.

Project Critical Path and Baseline Schedule

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.

Project Launch and Execution

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.

Project Closure and Evaluation

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

Francis

VIARES provided me with the formal training and skills that would allow me to achieve my career and personal goals. A chance to complete this course afforded me the opportunity to experience the clinical trial training from different experienced

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professionals, whilst providing me with exposure to the international arena of clinical research management and the global concerns while interacting with the multi-national specialists and students. I developed skills in report writing, clinical trial design, and data management among others. I would recommend the VIARES ACADEMY for anyone eager to set strong foundations in clinical research whilst remaining all rounded.

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Kiran

The VIARES CRA Academy is a great opportunity to build your clinical research skills. The program is well structured and provides knowledge on different aspects of clinical trials such as ICH-GCP guidelines, medicinal products, safety, and

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ethical considerations. Really helpful was the constructive feedback. I would highly recommend it to anyone who is seeking a rewarding career in clinical research.

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reviews curated by judge.me

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

clinical research online course - clinical research project manager

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Clinical Research Project Manager – Enterprise

€ 359,90

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€ 359,90

Clinical Research Project Manager – Enterprise

COURSE Content

VIARES CERTIFICATE

Hear from our graduates

Francis

Kiran

WHY BECOME A Clinical Project Manager?

WHAT ARE TYPICAL RESPONSIBILITIES OF A Clinical Project Manager?

IS THIS THE BEST OPTION FOR ME?

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