Clinical Research Project Manager

• 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.

The VIARES Certification is an online exam covering 100 questions from the VIARES training course. You need to complete the exam within 90 minutes and achieve at least 80% of all points to be graded positive. You have two attempts, of which the attempt with the higher score is applied for your certification.

After successful completion of the exam, you will be graduating the VIARES program and obtain your certificate.