I am the head of clinical data strategy and ops |
my organization is accountable for collection of clinical data in each clinical trials |
once all of the data is collected we do "cleaning" of the data. We also build the systems used to collect data. |
4 dif. systems |
we have offshore presence in India who do data cleaning |
we also do data insights tools, we interact with statistical programmers and statisticians and take that to approval |
we recently purchased an oncology research company |
company of 250 people, oncology company |
we have sister function within this new company but it is very small group but because they have different models and skill sets its important we integrate their systems into our own and as seamlessly and with as little disruption as possible. |
Also don't want to miss opportunities to improve our own operations |
we need a PM who can work with both the newly acquired company and the mother company so that we are seamlessly integrating into a single operating model. |
we have been working on the blueprint for last 2 months and the project is already underway. |
We have had the opportunity to interact freely with Immunogen and we are getting to the point where we need to do heavy lifting as far as Project Management goes. |
The PMs most important is experience is doing multi company integrations which is a hard ask no doubt. |
Nice to haves in order of importance from Left to Right are Life Sciences, Domain knowledge, Knowledge of clinical environments and knowledge of clinical operations and even some data management experience would be better. |
Next is some level of work with IT and integrations |
Also a multi-vendor environment experience |
What would you say is the biggest challenge out of the gate? Probably the people part. Its not that they don't work well its that they come from two different integration models. It is mission critical that we make sure the playing field is kept level. Biases left to the side and no feeling of one side being better than the other |
What technical aspects are required? The ability to work in Excel at high level as well as Power Point presentations at a high level. SmartSheets would be good but not required. From tech standpoint that is most critical |
Can you go into the nice to haves a little more? Yeah systems environment for our particular domain. That NTH is related to fact that our operating model at AbbVie is so unique that we have our own systems. At Immunogen they use contracted CRO systems . Eventually they will be combined so knowing GcP and regulatory background is highly beneficial. |
Are there any other nice to haves that you can elaborate on? When we think about Matrixed leadership there is obvious where we integrated 2 different companies. As mentioned, this is a sensitive environment and everyone is kind of doing things the way they have been doing and we need OCM control as we integrate. We had a very successful integration that went very well and we want to duplicate that success |
Q&A--Continued |
In regards to X-Integrations what experience should they have? For me the experience of having integrated companies is really the key it is such a unique experience and the ability to navigate difficult situations with finess is critical. Unless you have this experience I can't see how you could do this. Also that Matrixed leadership is a critical must have |
Clinical PM or IT PM with M&A? An IT PM is not appropriate, this needs to be someone with experience across people projects and technology. I don't want to go too far into technology area, they definiteley need people and processes. So Clinical Trial Project Management is what we want. |
Data migration from CRO data systems into a central AbbVie data systems and probably during that time we will start new studies using AbbVie technology but we will be researching integration of those systems at unigen |
Onsite? Onsite is not required, there may be specific situations where they may need to travel to Boston or Lake County but they can be virtual until that arises |
Is M&A experience required? No, I need integration experience |
Biometrics or other specific clinical trials experience they should have? They need to be proficient in anything I had mentioned earlier. Knowing the nomenclacher is important and knowing how the different systems are used given the biometrics they are in. |
Is SAS or other programming languages required? All the data once it is ready to submit the statistical programmers who then develop tables, listing and graphs. That's how the FDA is able to review our submission so they use SAS or R as main programming language. |
Life Sciences? It is the number one nice to have |