RBQM Ops 2022 - What roles and structures are required for end-to-end quality management

What roles and structures are required for end-to-end quality management?

SUMMARY KEYWORDS
monitoring, organisation, rbqm, data, risk assessment, quality management, central monitoring, opra ram, opra cm, support, process, study, strategy, manager, project, risk, platform,

DUNCAN HALL:

Now we're moving into the final section of the agenda. Now, perhaps arguably, it's the most importance of not having heard from many great speakers on the key elements of the end-to-end RBQM process, this last section is about putting it all together and putting it into practice. We've called it organizing for success. And I'm delighted to say that we've got two great speakers on our final two in depth topics.

The first speaker is Lisa Friedman, was previously the Senior Director of RBQM at dMed Clinipace, and soon to become the Director of Clinical Trial Management at Aperio clinical outcomes. And I've had the pleasure of working with Lisa for a few years now. And I've witnessed her efforts to drive the adoption and rollout of RBQM at dMed Clinipace, Lisa's going to share with us her insights into the roles and structures required for great end to end quality management. So Lisa, thank you for sharing your insights. And thanks for being here today. Over to you.

LISA FREEMAN:

Thank you so much. So excited to talk to you guys today about the roles of structure required for end-to-end quality management. And this is based on my experiences at dMed Clinipace as a senior director of RBQM, I just left Clinipace a couple of weeks ago. So this disclaimer, my opinions are my own, not related to any TRI or any organisation I've worked at and based on my personal experiences.

So for organisational development, I think that's, you know, key to think about this. Because really, this is a change in the way that we're working. And it's cross functional in nature. So, it does it is kind of a multi departmental divisional organisational development change management process. But first of all, looking at your organization's readiness for change, not all organisations are ready for change and this change particular. So, you know, you need to be sure that it's something that is is that we're on board for, and also take a look at previous change management initiatives. Why were they successful? Why were they not? So, you can do some kind of lessons learned. The other thing is what kind of culture does your organisation have, we've all heard that culture eats strategy for breakfast, so it's important to understand what your culture is, before you go into this because you may want to modify your strategies and communications and everything else based on how your culture actually works, which is how things get done around here.

So then the next thing is understanding your track strategy and scenario planning. So, you need to have someone in a leadership role, who's going to design the strategy for your RBQM processes. And for me, this took about six months, so I had to, you know, I didn't have to, but I read all of the literature there is about RBQM that I could find. And then I also had to spend time writing SOPs, processes, plans, manuals, etc. So being able to have protected time of six months was really important setting up the correct strategy. And then once you've got the strategy, do some scenario planning to determine kind of, okay, if I do these things, what might happen, which is an alignment with risk management, right. And then also, you'll note, I have a great article here that silent killers of strategy implementation, which is useful for any organisational change that you might come across, so, I think it's really helpful to look at that article.

Organisational structures, typically organisations have a hierarchical structure. But you know, the way things get done may be different, you've got influencers without titles, you might have more of a top down or more of a bottom-up type of culture within your structure.