Daily life of a Project Manager

hello everybody and welcome at our gcp mindset channel today we speak about a very pragmatic topic again especially for people who are interested in a career in clinical research or who are searching for a job we are speaking about the daily life of a project manager and i have invited sergey graf sergey is the head of our project management team and will let us know a little bit about the life of the project manchester thank you andreas for inviting me here and giving the opportunity to speak about my experience yeah thanks for being here [Music] hello sergey thank you very much for being here to speak with me about the daily life of a project manager i know you are the head of a project management department and um tell me a little bit more about yourself how did it come that you are now ahead of a project management team yeah thank you andreas so my background is that i'm a biologist like many who are working in the clinical trial area i've studied neurosciences in the university of bremen then i gained first experience as a cra for two and a half years but then i moved to a different position as a data manager and there i had the opportunity to work as a position where i could support both departments because i had knowledge in the theory area and could use data management approaches and combine these and this was also the first step when i then later gained first project management experience which helped me a lot and knowing both areas um later i then transitioned to a full project management position and after over three years in project management i had them the opportunity to become the head of the project management department great that sounds like a very nice career quite fast i mean seven and a half year and three years as a project manager i assume that you work very successfully as a project manager and that was the reason also why you have promoted to a head of project management so can you tell me explain me what makes a project manager successful the name says it's all andreas project manage the project manager needs to manage the project and to be able to do this successfully the project manager needs to know a few things for example um knowing the overall goal of the study it's very important not every little detail but what is actually the purpose of the study what resources does does the pm need human or electronic ones um also the basic procedural steps for example are very important to know not not that the project manager needs to know how a statistical analysis plan has to be written but he needs to know that one is needed and who is doing it and by when must it be finished a successful project manager focuses on the important topics of a study and the critical and important topics of a study usually mean an issue and or a problem and so the project manager needs to be able to to solve them this is part of the job solving this critical project problems because they otherwise the project will not move forward okay what kind of major or critical problems can we expect i mean every everything which is related to major impacts on the timelines or on the budget of the study or also on the end quality of the trial is a major problem i don't mean things like queries at one side queries on the other side but really the outcome of the study the end quality that could mean inspections findings or the output of the study does not have any value these are the quality issues that would be major and needs to be focused uh to be the focus of the project manager yeah okay when you say now the project manager needs to solve such problems and you say um the quality can be a problem for the study does a project manager need to improve the quality not directly but the project manager knows who in the team is responsible for these particular quality problems and needs to communicate with these team members to find an effective kappa to resolve the quality issue okay that means that communication is a very important task for project manager a daily task yes communication is very important but communication does not mean just to talk or what some people do to complain about problems but to effectively identify the problems communicate what happens and to find solutions and for that also to communicate effectively with the team what are the options is some information needed to identify which is the best option and then go for it okay communication is an important task of a project manager but what else are they doing during the normal daily life another important task of a project manager is vendor management for example the cr cro or a central lab furthermore consultancy of the team or the client is very important based on the experience of the project manager an example would be to advise not to to run the study in a certain country because of the regulatory environment there which wouldn't have a very much delay in the timelines to start the study or because the investigators in this country are not paid for the extra effort in a clinical trial but just the hospitals which would demotivate them to participate in this trial so you would also tell a sponsor please don't go to this country or don't go to that site even they consider them as key opinion leader because it's not helpful for your project for sure because my interest as a project manager is the interest of the success of this study and not certain key opinion leaders and it would make the study better to not go in certain sites or countries it would be better yes budget controls and control of timelines is also very important task of a project manager let's imagine you have a study that is planned for 12 months but due to delay it now runs twice as long the logical consequences of course if you want to remain in the same budget you need to reduce the intensity of your activities for example the monitoring visits should be reduced by 50 percent if you of course say no the intensity is very important the logical consequence again is then to increase this the budget to be sufficient for this now twice as long period for the study this goes also into the next task in the direction of planning studies planning is very important because um let's imagine you have a study which is which lasts in the active phase 24 months so first patient in until last patient out but every patient in this trial participates for a 12 month period this means you are only left with 12 months to recruit all the patients and in this scenario you have 800 patients to recruit with eight sites this would mean every site needs to recruit around eight patients per month every month for 12 months to be able to reach this goal i would say this is not something which is feasible or realistic okay but what's your job then yeah i mean you assume already that the numbers are not realistic and now what's your part then in the game then we come back to the task of communication the project manager here needs them to communicate to the decision maker and communicate the realistic situation but without being too pessimistic in the communication okay and the reason for that is that nobody likes to work with pessimistic people exactly okay sergey i think it's quite hard for you as a head of a project management team to measure the performance of your team because you speak about negotiation about communication about planning and so on and that's not so easy to measure in in terms of key performance indicators how are you doing that we spoke about earlier that project management basically means quality timelines and budgets and the kpis can be found also in these three aspects you can measure timelines you can measure if the budget is kept as planned and if the required quality is provided and a special point i want to mention to the budget the budget must be kept by the project manager not only to his or her own budget for project management but of course needs to be overseen what are the other departments doing if they also keep the budget for their tasks overall okay that means that the project manager has actually the role of a mother or father within a family so yeah so complete performance of the whole family and not only the performance of the parents when you speak about family as a project yeah so really it's a very emotional relationship you have to your project it's like taking care of your baby that's right that's very true okay we spoke now a lot about tasks of a project mancha what would you think what are the skills somebody should bring into the into the role of a project manager to perform well let's differentiate here a little bit there are a few things that you should bring directly with you when you become a pm for example being able to communicate with people so to like also to like it if you consider now a person who is very introverted and does not like to talk to people they may be good also in communication effectively but only in text form but as a pm you need to be able to talk in calls with people calling them so communication and being able to communicate well with people is a skill you should you should have from the start um another skill is to have structural and logical thinking if you remember the example in the planning where you need really to consider does it make sense in the future you need to plan ahead you need to plan the steps in the study in a meaningful and structural way so the skill of structural and logical thinking is needed to be a successful pm and and then another one which you can bring yourself directly into the job is being flexible and by flexibility i mean uh if you consider we are working an international environment where countries have differences in how they are structured how they perform studies what are their requirements and also the culture is different and you need to be flexible enough to to adapt and how that other countries work differently this is one point of flexibility and the other one is that the studies are nowadays conducted with more and more technology and you have must be flexible enough to to adapt to these new technologies being open-minded to that for example currently we are using and we are working with excel and you need to be able to work with it to since you are working with budgets you need to be able to quickly generate overviews using excel but in 10 years it can maybe something different and you should be open-minded for that okay i think what you just called initial skills i would more call attitudes that's what people learn at school and from friends and from parents and so on but what kind of skills do you train them how do you develop your project management team to be well-performing project managers yeah so let's say let's call them the advanced skills a project manager should have and that he's getting trained on when he's doing the job is for example the understanding of urgency or prioritization of tasks we talked about that the project manager needs to focus on the critical and important tasks so the he or she needs to be able to differentiate what is urgent and important so this is a task that they need to know and to learn as an advanced skill another one is we talked of course about that you need to be to like to communicate with people but not just small talking or talking but um result directed communication um so this is something that that we train our project managers that they focus on the result and on the problem and direct the communication that way for example also leading through a call leading through a meeting because then you use the time effectively on the topics that needs to be discussed and not just talking together yeah yeah and this goes into the next skill which is let's call it leadership um where you also lead through the meeting and you also are as a leader you need to be able to delegate tasks because you have project management tasks but of course in your team there are other people there are data managers there are tmf managers regulatory people statistician and they are all doing these tasks you don't do them so you need to be able to delegate tasks to other people but at the same time if something goes wrong as a advanced and good project manager you are able to take the criticism and not blame others okay very important what's with budget i mean we don't do anything for free usually in business um do you also teach them how to control budgets yes of course you don't learn this in school so from where should the pms know this yeah so developing and being able to develop an understanding of how budgets work and how to work with and control them um this is a skill that is developed great thank you sergey what i see very often is that people are starting in clinical research maybe as a cta or cpa so as this assistant then they continue as a clinical monitor or cra traveling a lot and at a certain moment i say i don't like traveling anymore because of family reasons or i just got tired from traveling and then the next logical step for them is now i become a project manager do you think that's the right approach this is for sure not the right approach we talked about the necessary skills that pm must have to be successful in the number of years you're working in the industry does not mean it's not a proof that you have these skills you can have on the one hand cra who has experience of 10 years as a cra but they don't like to lead or they don't like to work with budgets so they don't have the skills and so therefore they are not suitable to do this job on the other hand you can also have project managers who do not have any experience as a cra but they can successfully communicate they have an understanding of budgets they think globally on the important topics and these people have the right skills to become successful pms and they are more suitable than those who have a lot of years in the in the in the studies in the environment okay that means um that sometimes even extremely good cias were really really good in their job might become very weak pms correct yes of course because the tasks are very different yeah you don't control everything now on detail source data verification but you have now to have the global overview and focus on the important thing and not on every query yeah so that's no logical step to develop from a clinical monitor or cia to a pm no okay sega you you're working together with your team and a cro providing project management services to the pharmaceutical and medical device industry and i think you also need to keep in mind the satisfaction of your clients so what do you think is important to satisfy clients as a project manager regardless if their client comes from a medical device company or a pharmaceutical organization to make them satisfied you need to be able to take their worries away from them they hire you to run the project and you should do it so that they do not have to worry but at the same time if something happens and issues happen in studies you need to transparently communicate these problems not hiding them because then you can develop trust to the client you show what goes wrong and you provide proactive solutions for it consult what would be advisable to do but in the end the client can decide differently but that what you provide you provide proactive solutions to things that happened to problems that happened um the same thing goes into the direction with a budget if you notice during the study that the planned budget is not sufficient and this should be proactively communicated to the client so they can think about what could what could be done maybe there is a need to change the strategy of the sdb for example that not all data ssd but only those that are essential to to reduce the needed number of visits and by that the budget and to stay uh to to keep the budget and yeah okay now i can imagine that you have a huge variation of clients some have a lot of experience some have nearly no experience so then the project management also needs to think very empathic so that they really understand what is the need of that particular client that's true some some just want to give away the studies here's the budget here's a study do what's needed to reach the goal and you can decide but others want to be involved more and you need really transit what is what do they want not what i want as a pm maybe there are is a pmc everything must be 100 is defeat but that's not what the sponsor wants if they don't want it you need to think what the client wants and then organize this as efficiently thank you very much sergey and as you know we want to reach also young people who are interested in clinical research and finding a job in clinical research what would be your recommendation for young people if they are interested in the project management role i would recommend to be interested in also what the other departments in the company do and what obstacles they experience to gradually develop in a broad overview of the business and of the clinical trial environment which you need as a project manager to think outside of your area of work another recommendation would be to if you run into a problem don't just come running immediately to this to your superior first think about one or two solutions to that problem and then maybe you can ask your project manager or your superior um this is good to develop a problem-solving mindset that you first think yourself about what could be the solution to it this is a recognition i would give to young people and i would like to conclude also with a recommendation that be patient if you make mistakes it's not the end of the world um you will learn from it and yeah be patient yeah i completely agree i think um being patient is anyway a very good advice um and i think we are also responsible to tell people who should not become a pm because of lacking skills or attitudes what do you think who must not become a project manager someone who cannot delegate tasks to others and wants to control everything and do everything by themselves they should not become a pm they are too slow and cost ineffective um also people who are um spending their time with micromanagement because they cannot differentiate differentiate with what is important and what is not important should not become pm and people who feel to make a decision or cannot make decisions because they are afraid to make a mistake and the bad consequences that they get bad consequences from that these people should not become pm because all of these people massively delay the study progress especially in the study startup phase where you have to make a lot of decisions yeah but the the the tricky part or dangerous part is that you can have such a control flick let's call them on either the cro side or the sponsor side and it is sufficient that one of these is is there to delay the work of the other person and by that delaying the whole project progress okay yeah thank you very much i also completely agree with that and i think control freaks have anyway a bad future because software can control data and make micromanagement anyway much better than people can do that's true yeah okay thank you very much it was really interesting to speak with you about the daily life of the project manager and all the skills and attitudes and tasks really thank you very much for that i hope that you also liked our video please leave your comments send us your questions subscribe to our channel and see you the next time bye bye [Music] bye you

Channel: GCP-Mindset - All About Clinical Research

Views: 2,775

Rating: 4.9191918 out of 5

Keywords: PM, project manager, cro, clinical research, clinical project management, clinical trials, how to become, pharma, cra, research, clinical monitor, pharma industry, klinische forschung, interview, medical device study, pharmaceutucals, tials, budget, compliance, gcp-service, project management, clinical research organisation, clinical research associate, klinische Forschung, klinische studien

Id: aRnzi4tmmKs

Length: 23min 25sec (1405 seconds)

Published: Mon Nov 02 2020