GCP-Mindset: Daily life of a Data Manager

hi guys and welcome to our gcp mindset channel today we continue with our videos about jobs in clinic research and today i have with me a data manager of the data management department on uen thank you andreas happy to be here and i hope that i can share some insight into my job as a data manager thank you very much for being here and enjoy the video and thanks again for being here to talk with me about data management honestly i don't have so much experience with data management i worked for many years in clinical operations in qa and have done a lot of different things in clinic research but never in data management and i think it might be very helpful for people who are interested in clinic research in finding a job in clinic research that you give them some advices recommendation or just explain what you're doing the whole day and um i know that you are not working for many years because you are still young but still i think you have done a lot of things already you can share with us um yes so actually i studied chemistry because i always had a strong interest in math science and technology and i really enjoy coming up with new ideas and solutions to problems that people put in front of me and then during the course of my studies i just realized for myself that i really enjoy dealing with the data itself but maybe not so much standing in a lab and generating the data so when i came upon the feed of data management and clinical trials it sounded kind of endearing to me because i could still work in my field of interest and contribute to the development of new treatments for patients this time i could actually um just focus on the data and just cut out the standing in the lab part of my job basically and uh so i thought it makes sense and should try it so i started learning about the world of clinical trials about the role that data management plays in this and also started acquiring the skills necessary for that job so i picked up programming learned about databases learned about edc systems and yes so about a year ago i started as a cro as a data manager great that means you enjoy that you don't produce the data but you deal with them somehow yeah exactly that's i enjoy that quite a lot exactly yeah great ann you mentioned already a couple of tasks you're doing but let's come back to the normal day of data manager maybe you can start with just a data manager comes into the office and what then yeah i'm not sure if it's because i'm still feel like i'm relatively new to the job but i it's kind of difficult to explain a typical day for me like i'm still learning a lot new thing a lot of new things each day and maybe that's that's the typical thing actually about a data manager we there's always something new to do for us because we have a large variety of tasks that we have to do um so maybe let me explain it a little bit more so when it comes to a specific study project we are involved in the study startup that means we received the clinical protocol and then according to that protocol we designed the ecrf and also the validation checks uh to make sure that the data that is entered into the database is consistent yeah but uh i need to stop you please remember two years ago when you were new in the job you also did not know all the terms you're just using so maybe we need to explain it a little bit easier to make it understandable for the guys who are interested in such a job okay yes um so a little bit easier so the ecrf uh electronic case report forms yeah in the past it's been done on paper but now like we do it more electronically so that's why like we did we program that and so that can be entered directly into a database electronically and then validation checks is basically like when you enter the data into the database we can program some checks to make sure that uh um the data is consistent for instance when we um record a start date and the end date we can program an easy check that makes sure that an end date cannot be before start data it's logical and yeah and that cannot be entered into the data um so we do that also in close contact with our clients so make sure that their wishes are fulfilled and then specific for us data managers in the startup phase we prepared a data management plan where we actually um describe and just define all our procedures processes that we will follow throughout the study and also our responsibilities and timelines um this is uh we use this document basically to um to base all of our tasks during the study on as a data manager and apart from that we also prepare data entry guides and train the study staff on our ecrf that we designed obviously and then we can also in the startup phase already prepare like thinking about reports that we can give to the study team members to help them monitor the study progress so that is like some of the tasks we do at the beginning of the study okay but that is a very central job yes you're working with uh sponsor you're working with a monitor you said you also need to keep in mind the investigators and site staff study nurses and so on because they need to enter the data then you need to program you need to validate so it's it sounds quite complicated exactly like i think the startup phases can really like the the the most intense time like for for us because there is so much we need to prepare and as you said we need to be in close contact with so many other study functions and make sure that uh like what we design our output or ecrf is really something that everyone can work with and so yes so that's that's a lot of work in the beginning uh but then once it's finished we can just like look forward to having the first patients enroll in the study and okay from there yeah and what would be the next task then when data are coming into the system okay so now we move on to the study conduct phase so here we uh as a data manager we deal with all things data related so we perform our tasks that make sure that all the data in the study is tracked correctly and then we do everything that we can to make sure that the data collected is complete is uh consistent and is accurate and besides that we are on constant still in constant exchange with all the other other study members and always be there to provide support input or reports if it's necessary yeah yeah but you you cannot manipulate the data somehow even so it's obvious that there was a mistake for example when the investigator make a mistake and exchange um the systolic blood pressure and the diastolic blood pressure you you you know that's incorrect but you cannot correct it by yourself correct uh yes so we program validation checks beforehand and with with them we can see them automatically we don't have to like look through all the esls by ourselves and like track it ourselves so when there's things we program and whenever we we find these things we uh can raise queries so we asked the site to actually like look we found some inconsistencies please confirm that or change it yeah and then we follow up these procedures and if it's changed so that this makes sense now we say okay all good and we close the case basically okay that means that your job actually stops when the last patient is out of the study actually not like after the last patient finished the last visit uh we we get into the next phase of the study the study closeout phase and there we as a data manager prepare for milestone which we call a database log so we need to make sure that the data in our database is consistent and ready for analysis so any open issues that are still there we need to follow up and close the issues and yeah once we we finish that we we can say like okay our database is complete and makes sense um we can hand it over to device statistician so they can perform the analysis on it but even then it doesn't stop for us then we need to prepare the data archival and also it's also possible that we just contribute to the programming of data listings for the study okay that sounds quite intense like the first phase you said you you handed over to the biostatisticians for analysis so that's no data management tasks the statistical analysis yeah but what is with coding i know there are several dictionaries on the market the us have cds dictionaries or codings and are you also involved in that as a data manager so yes as a data manager we also involved in these things within our team we have experts who actually actually like know a lot of about medical coding for instance or cds standards and satm but because they are reliant on the data so me as a data manager i can just pull the data prepare the data for them so they can perform the coding test easier so that's why like anything data related uh we are involved in and we should also know what the the experts and the the functions actually have to do so we can provide our output accordingly yeah so everybody depends on you as a data manager if in ventured out um because like the data is quite uh central for for our study members and the data is our area expertises you can say it that way yeah okay that sounds like a lot of responsibility you carry with you um really interesting um what is in terms of the location of your also your working place is it a typical office job or do you work from home base i mean nowadays everybody can work from home um but it's a typical home based job you're doing as a data manager so okay if we compare to the cras we don't travel and don't see this clinical setting at all so if you see it like that data management job is like a more of an office job where we uh work with a computer a lot when it comes to working from home we obviously have flexibility so when we have a plumber coming to our home we can on that they definitely work from home and perform our tasks but uh in general like uh because we are in like so central to the study like it's good if we show up in the office from time to time just to be there and make communication easier so we can have this constant exchange and solve problems just faster that way yeah so i always say clinic research is really a team work um job and so it's also you are important part of the team so it's good also to meet face to for better meetings in data management we had a lot of changes during the last couple of years um because 20 years ago we have done nearly everything on paper and then data needed to be entered into the database and data manager are judged by as well especially the data entry person are judged by the number of data per hour they have entered into the system it's like the the people at the cash machine in the supermarket fast people are better what are the typical key performance measures um nowadays for data manager how how is your job measured or how is it decided that you are working well so if we look at into the study as a whole uh like for a successful study we need to ensure patient well-being and safety but then when it comes to data which we data managers can have the most impact on i feel we need to ensure like high data quality and integrity so all in all if a study runs well and is concluded in a timely manner the whole study team can take pride in it and obviously us as data manager as a part of that team can take pride in it too um so but then if you want to speak specifically about data management kpis um let's say like how we train the staff how we prepare our data entry guides so that it's easy to understand obviously it will have an impact on the study conduct so that there are less mistakes by data entry uh and then also the way we um communicate so whenever there are some inconsistencies in the data how we like raise the queries and then if we don't explain it well enough maybe like the the site asks i don't understand what you mean can you explain again so you have to do it once more and it all takes time and it's just also added stress to the other party so so on a small scale like when we communicate well it's uh just means that it runs runs well and then also like just in the past when data managers used to enter data from paper into the system uh still now like um it's important that we keep the number of errors to minimum and also perform our tasks in a timely manner so as an example the the database log so one after the last patient finished the last visit and the time starts running and we try to clean up everything and um i feel like the the better our work was throughout the study the faster we can perform this database log and um hand it over to the statisticians so they can perform the analysis and i ideally we just look at once and it's all good but sometimes like doing analysis like they find some problems and then we need to unlock it uh clean it up and lock it again so obviously uh if we can keep that number down so this number of mistakes down is obviously better because it also means that we save time yeah so your impact on the whole study duration is is extremely big isn't it yeah so i think then the your job is quite often underestimated in terms of responsibility i mean like i don't know what other study functions think of us but yeah like i understand that a lot of people rely on us so we need to do our job correctly at all times exactly okay so i learned you have a lot of responsibility you work always against the time and what would you say what are the important skills for people who want to work in the data management field so we are working with a lot of different people who all have their own individual timelines to keep to so strong organizational and planning skills are very important for data manager so especially when you are juggling multiple projects that you are able to prioritize tasks and also delegate tasks whenever necessary then uh also what is important when it comes to dealing with the data we want high quality data so you need to have a precise working style with an eye for detail and then finally obviously like there's a lot of technical knowledge that you need to have in order to perform data management tasks so you need to know about uh regulations obviously and then about edc systems and then also like depending on what tasks you later on want to like specialize in like some programming knowledge is always welcome then maybe knowledge about medical coding what we talked about data reconciliation or also like see the standard stm for instance like this is some of the skills that you need to bring as a data manager okay so um i mean all the technical skills but also medical skills i think you can learn exactly like at the job exactly look you can learn a lot on the job and uh as i said like it's it's nice to have that when you start but you can like pick this uh things up on the jobs as well yeah but as as far as i understood empathy is also important because you work with a lot of people who have different skills i mean for example you are working with site staff where you have nurses medical doctors then all people of different ages as far as i know you have also experienced with epro where patients are entering data directly which have again a completely different education um level compared to the academics maybe not always but uh quite often uh that means that you always need to think how these people would use the edc programs or software you are programming for them exactly so like you need to take different perspectives into account so i understand that um not everyone thinks like you especially as uh we are like data driven so sometimes like like we think in numbers like uh ones and zeros sometimes and like for normal person is like super complex and they don't get it so we need to have that in mind as well when we design our um systems yeah and i think that's the hardest skill you can learn to to think from the different angle whereas the medical and technical part it's it's easier and you're working currently for co and i think you delivering your services to a pharmaceutical companies biotech other health care companies also medical device companies do they have different expectations um in terms of data management what they expect when they are communicating with you okay so we're providing data management as a service so that's why we have to understand that we have to make sure that we always have to respond to our clients specific needs and preferences so each client each project is different so we cannot always like act the same and work the same so flexibility is important when we deal with our clients and then also like what we talked about a lot uh we need to cooperate and communicate well with other people to make sure that the study runs smoothly and the high quality data is obtained for our clients okay but are there different approaches in the different uh for the different clients i mean are people sponsors at medical device companies differently to sponsors in the pharmaceutical industry um so like i feel like uh medical device companies they are like um they are they understand us a little bit more like because uh they they work in a similar way as us and uh so so there like uh we can just uh be be ourselves badly and uh yeah there are also a lot of technic freaks and engineers and and so on and okay here where's the pharmaceutical company i can imagine um it's it's more emotional that's my feeling at least and when you work with sponsors for especially bigger pharmaceutical companies that's a lot about ego and or different kind of emotions control is very important but a little understanding really for data and data-driven approaches and data management at all yes um probably you can you can say it that way so yeah okay you explained us already that actually you have not really a normal day but typically tasks you do on a regular basis um do you also have something like ad hoc tasks you need to do from time to time okay so as a data manager you should actually always be prepared to react whenever there are problems that arise during the study that need our input when it comes to a specific example for instance there is a protocol amendment a particular change and then you need to adjust the ecf quickly and also the documentation that is related to that like the entry guys and maybe retrain staff on the adjust adjusted ecrf and obviously that needs to be done quickly and we need to perform it also like without any mistakes um and also like sometimes like the sponsor like us can you give us data for this patient we need to review it internally and then we just provide that data set to them as well in a quick manner okay so there's also a lot of flexibility yeah okay let's go back to quality what would you think what makes an excellent data manager as a data manager you need to have i think like flexible problem solving skills so we need to understand that we have to balance the expectations from our clients with the constraints that exist from the systems that we use and also the regulations so always like like solving problems and then um like a team throughout this talk like this strong communication and teamwork skills are very important you need to like take your time and make sure that you understand the tasks and needs of the other study team members so you can actually tailor your output to their needs um and then finally what i think is uh important like in our field there are a lot of technological advances currently because of the use of e-tools so you should be open to test and try new ideas processes and just figure out like what you can maybe use in the future to help the study runs better okay ann it sounds you love your job and you really find what you like to do in data management what would you recommend to other people yeah young people who are interested also in the data management job what would be your recommendation so if you're interested i would say you should just apply and interview for a position at a starting position at the cro because it's important like that you gain hands-on experience because the world of clinical research i feel like is very complex and from my experience like a year ago i didn't know a lot about it and like then like once i i was in the job i learned so much from uh like hands-on experience and so yeah just just try it apply and once you're in the job then my suggestion would be to be patient because uh obviously when you're just starting nobody will give you like full data management responsibility for a project by yourself so just be there and try to support your senior staff members as much as possible and learn from them and um also like stay curious um and just uh when you like apply processes that are new to you and um you need to understand that whether um there are a lot of regulations in your field which can be very daunting at the beginning like that's what i felt at the beginning like wow so many rules um but actually like the processes are not fixed and not perfect like there's still always room for improvement and if you see like maybe you can um try something different something new that will be better be more efficient then just talk it through with your senior team members and uh realize that idea and then you can even have a impact from beginning on yeah i think that's an important attitude especially because you need to work always against the time that you try to find a solution which makes you faster faster as a team yeah um but that's you can't study data management at the university it's always training on the job correct um so i think there are like classes and courses but it's just all like theoretical knowledge and so you can read it in the book as much as possible but actually like when you are in there you realize for instance you need to like work so many people have any uh personalities that you have uh to like act accordingly and just get used to it and you're always people are different that you cannot just like treat everyone like uh talk to everyone in the same way yeah essence so learn that understand that and act accordingly and just like that's why like experience in the study itself is really very important for you as a data manager so just try that and once you have that experience you can understand more if it's something for you or maybe not okay and who should not become a data manager so let's say like obviously uh if you're a state of data if you don't like working with people if you don't like working with computer and uh technology then it's not for you but yeah to be more serious maybe a more serious advice you have to keep in mind that sometimes the timelines are very tight so sometimes you have to work through quite stressful times so be prepared that you have to do that and also i think what is also important to understand is that the field is still very compliant and regulatory focus so some tasks and data management can feel tedious especially when you have to repeat them and also provide all the documentation that you need to provide obviously and if you don't like these things like probably data management is not for you but thankfully as i explained not everything is the same in data management there's also other tasks which kind of balance this out so it's not all like documentation and repetition um but it's definitely part of the job so if you understand that too yeah but you need to have from everything a little bit so if you're a nerd who just likes to work at the computer and doesn't like to work with people it's not the right job yeah if you uh you don't like rules legal rules then it's not the right job but if you just like people but no computer work it's not the right job so it needs to be balanced yeah yeah very good thank you i think stress resistance is very important in clinical research anyway in every position not only in data management and if you don't have it you should not work in clinic research yeah thank you very much it was very interesting and i really felt that you love your data management job and that you've found the right passion for you it sounds really great thank you it was my pleasure yeah thank you very much for listening to us i hope that you liked our video especially for the people who are interested in becoming a data manager if you have questions if you have comments please leave them in our comment section please subscribe to our channel it's very important for us see you the next time bye bye bye you

Channel: GCP-Mindset - All About Clinical Research

Views: 1,762

Rating: 5 out of 5

Keywords: CRO, clinical trials, trials, interview, budget, clinical research organisation, cra, clinical research associate, klinischer Monitor, research, pharma, pharmaceuticals, Pharmazeutika, klinische Forschung, pharma industry, Pharmaindustrie, klinische Forschungsorganisation, ethics committee, Ethikkommission, benannte stellen, notified bodies, gcp-service, Andreas Grund, compliance, clinical monitor, Data, manager, Data management, Management, Day in the life, Data manager

Id: UjbIExNKXbk

Length: 29min 28sec (1768 seconds)

Published: Fri Jul 31 2020