CONFERENCE PRESENTATION · SCDM 2021 Global Conference
Have you brought an umbrella on a cloudy day? How to apply risk management skills to data management tasks
- Session Type: Panel Discussion
- Session Level: Intermediate
OverviewThis year’s COVID-19 pandemic has shown us that there are a lot of uncertainties in this world and how our work and life can be impacted by these uncertainties. Uncertainties may lead to unplanned events, which may become risks or opportunities on a project. Implementing risk management is like bringing an umbrella with you when you go out on a cloudy day. It may not rain but it is assuring to have something to cover yourself if it actually rains. It helps reduce the negative impacts of unplanned events. Risk management is not a one-time task. It should be implemented from the project initiation to the project archival. Risks should be identified, assessed, monitored and mitigated on an ongoing basis. Thresholds should be determined up front. Tools such as RACT should be implemented. The evolving role of clinical data managers requires us to obtain and master new skillsets including risk management skills. At this session we will discuss how to identify, assess, manage, and mitigate risks and uncertainties proactively and consistently in order to keep one’s project on track to meet study objectives. Panelists should be senior level Data Management staff who have advanced knowledge and hands-on experience performing risk management while managing a data management project from initiation to archival.
Panelists will share their expertise and experience on risk identification, risk assessment, risk management and risk mitigation from the perspective of a Clinical Data Manager. They will discuss what risk management entails, how to assess data management-related risks qualitatively and quantitatively, what tools and techniques to use to perform risk management, what mitigation plans one may implement to reduce risks, and challenges and lessons learned from real-life scenarios. Panelists will use examples from work to support their discussion. Panelists will provide some tips and best practices on how to perform risk management as a Clinical Data Manager. At the end of the session, panelists will open the floor to address questions from the audience. The targeted audience for this session are junior to middle level Clinical Data Management staff.
After this session, the audience should be able to understand 1) how to plan for risk management, 2) how to perform risk analysis focusing on the probability of occurrence and impacts of identified risks on project objectives, 3) how to apply risk management skills to data management tasks (including tools and techniques), and 4) to identify mitigation plans based on the risk attitudes and tolerance levels of stakeholders.
What You'll Learn
- By the end of this session, audience should be able to understand how to plan for risk management during study start up.
- By the end of this session, audience should be able to perform risk analysis focusing on the probability of occurrence and impacts of identified risks on project objectives.
- By the end of this session, audience should be able to identify appropriate tools and techniques to apply risk management skills to data management tasks.
- By the end of this session, audience should be able to identify mitigation plans based on the risk attitudes and tolerance levels of stakeholders.
Meet the Presenters
Manager, Data ManagementDr. Hui (Tanya) Sun is a clinical project manager (PMP certified) and clinical data manager with strong research background and extensive industry experience. She has about 20 years of progressive experience in clinical data management and 15 years of clinical project management experience on domestic and international projects across different therapeutic areas. She is currently a Manager, Clinical Data Management at ICON. She holds a Ph.D. in Public Policy. She is the Chair of the Membership Committee at SCDM.
Data Management Trial ManagerJulie Stielow is at Data Management Trial Manager at Merck from West Point, PA, USA. She has 15+ years of clinical data management experience.
Lead Data ManagerChelo Gonzalez works as Lead Data Manager in ICON plc (formerly PRA Health Sciences) since 2020. Her background comprises 10 years of experience performing tasks both as data manager and statistician across several therapeutic areas. She previously worked in Experior, a small CRO based in Spain.
ICON (formerly PRA Health Sciences)
ICON (formerly PRA Health Sciences)
Principal Clinical Data Manager
PriceSCDM members: €50
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