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- Get properly trained
- CV, CV, CV
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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.
Our Expert Instructors
Vince W
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Cynthia L
CRA Instructor
Jessie C
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Lauren M
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