Some time ago we introduced you to Dr. Liliana Borsellino and her role and experience as Customer Relationship Manager. Now, Dr. Hella Mühlbauer, another crucial member of the Business Development team, tells us about her position and experience as Account Manager. Since the beginning of the year, she has been responsible for the feasibility process, which plays a central role in winning new projects for the company. In the interview, Hella explains the tasks involved and the challenges she faces on a day-to-day basis. She also reveals how she manages to maintain her work-life balance.
1. When did you join emovis and what did you do before that?
I joined emovis in January 2022 as part of the Business Development team responsible for feasibilities. In fact, a former supervisor recommended me because she thought I would be a good fit for emovis. She also knew that I enjoyed monitoring studies at emovis as a monitor 20 years ago.
Before that, I worked for 20 years at one of the largest international contract research organizations (CRO - Clinical Research Organization) and then for five and a half years at a smaller company that also acted as a link between the pharmaceutical industry and study sites. So, I've been involved in clinical research for a very long time now, but always more from the CRO or pharmaceutical company perspective. I've worked as a clinical monitor in study sites overseeing studies and I've also worked briefly as a project manager reviewing monitor reports for quality in global studies. I worked as a study coordinator and managed the electronic Trial Master File (TMF) for a major client - i.e., the digital storage of all essential study documents according to strictly defined rules. In the area of patient recruitment and retention, I took care of which patient materials for the studies were requested by the study team and then organized them and took care of them until the printing order.
2. How has your previous experience helped you in your current work?
A basic understanding of how clinical trials work is of course very helpful and even though I have worked in many trials and with numerous indications, I did learn something new every day. I work a lot with the feasibility process, which is about the different indications and the different study designs for each study. It is very interesting to get to see the different perspective of the study conduct from the study site’s side.
3. You are responsible for the feasibility process at emovis - what exactly does feasibility mean and what does it stand for?
Working on a feasibility means assessing whether a study or project is suitable for the study site or for one of our other services, such as Homecare Visits or the Patient Access Group. This means that I first check whether we have already conducted studies in this indication and whether we were able to recruit sufficient patients. I also check whether we have the appropriate physicians and the experience to conduct the study in question. Then I ask my colleagues how many potential patients we have in our large patient database that we can ask to participate. And of course, the director of the study site, Ninon Armbrust, assesses whether we have sufficient capacity and personnel for the entire implementation at the planned time.
4. Can you tell us how a feasibility process works and introduce one?
I either search for suitable projects in various portals where studies are listed and my colleague Dr. Liliana Borsellino then puts us in contact with the client. The other option is that we receive direct requests for specific projects. Most of the requests come from CROs.
My colleague Dr. Liliana Borsellino is responsible for general client contacts and I am then the primary contact person when it comes to a specific project. We then fill out a questionnaire that asks for general information about the study site; for example, questions about the investigators, the experience of the staff or the equipment. In addition, I also have to give an estimate of how many patients with the corresponding disease we can enrol in the study and in what time frame and also what promotional materials we would use for recruitment. Here, we can always refer to our own patient recruitment team, which has been very successful for many years in drawing the attention of patients to our studies with customized advertising materials and campaigns in a short time. This task takes a lot of time: From the contract management to the creation of the texts for the advertising campaigns and the subsequent submission to the ethics committee, many steps are necessary before the first screening of patients can begin.
If the client then decides, based on the information we provide in the questionnaire, that we are qualified to conduct the study, a qualification or selection visit takes place at our study site or virtually. This is carried out together with the employees of the study site, the corresponding physicians and project managers and/or the head of the study site. Details of the study are discussed and about 6 weeks later the clients decide whether we can participate in the study. If we are selected, the contract development and processing begins. The required documents (e.g. CVs, training certificates, list of study experience and general information about the study site) are collected and forwarded to the CRO or to the client. Subsequently, the entire study documentation is submitted to the Ethics Committee. Once we have received a positive vote from the ethics committee, an initiation visit can take place, the advertising campaigns can start and when we have the medication and all materials, the enrolment of patients can begin. It is difficult to give an example of a concrete feasibility process, it would take too long. However, the principle is the same everywhere, only the number of questions can be very different.
5. What are the biggest challenges you face and what needs to be paid particular attention to?
The biggest challenge is to correctly understand the disease being investigated in the study and then to assess how many patients there are in Berlin who could fit into this study and how willing they are to participate. I am very well supported by our physicians and the director of the study site. In addition, it is important to check in advance whether we have to contract specialists from outside and whether the required examination methods can be performed by us at all or whether they have to be performed by other institutions (e.g. X-ray, MRI).
6. Describe your job: what does a "typical" workday look like?
I usually start work very early and first check our shared email inbox, to which all of us in the Business Development team, including our managing director Dr. med. Bettina Bergtholdt, have access to. It is important that one of us is always there to respond to any customer inquiries within 3 days at the latest. I also handle the requests for projects from the Homecare Visits area, where we send homecare workers to patients' homes in 16 European countries to conduct study visits there. This is especially the case when patients have a very rare disease and/or the study site is too far away from their home. By doing this, seriously ill patients have the opportunity to participate in new scientific studies.
When a request is made, I check whether we offer our service in the requested countries and whether the requested activities can be carried out by nurses or if special paediatric nurses or even doctors are needed. Once these and other questions that may arise have been clarified, our budget department can either prepare a cost estimate or review the one provided by the client. If, after the contract is signed, a study site requests a home visit with a patient, our HR department will take care of it and check if there is already a home visitor with the requested experience in our pool of staff, who lives close to the patient and if he/she can also take care of the patient during the corresponding period of the study. We also receive requests for call-backs or information from potential study participants via our shared email inbox. We then answer these ourselves or forward them to our colleagues at the patient hotline. We of course also receive the feasibility inquiries for our study site that I explained earlier via the e-mail box. In addition, my colleague and I regularly present the Business Development team to sponsors and contract research organizations in meetings and try to win new interesting projects for one of our various services.
I am also in constant contact with the other departments because I need input for my assessments and my colleagues also have to prepare cost estimates for our customers. Since all departments support each other very well and always work hand in hand, the work is a lot of fun.
7. What do you do particularly well in your job? What are you particularly proud of?
My open and communicative manner helps me to quickly establish contact with potential customers and promotes good teamwork. Creating clear lists is also one of my strengths and helps not only me, but also many of my colleagues. I try to document everything I come up with in such a way that I can always access it quickly and don't need to spend time researching it again. So, for each indication I create an information page with the most important, relevant data - such as an overview of the disease, the symptoms and the frequency of occurrence in Germany (and then estimated for Berlin), the therapy options and the drugs that are already on the market for this disease. As a result, I learn a lot about new diseases every day and that is really very interesting. In my almost 30 years of experience, I have come across diseases that I would never have thought existed. Among them very tragic ones, where many children are affected. In these moments I am very happy that my family and I are healthy and that emovis can help sick people by providing numerous studies and the Homecare Visits service.
8. What do you answer when strangers ask you about your job?
I answer that I work at a study site that conducts clinical research around Berlin. We combine a site management organization and a study site in one and also offer many other services related to clinical studies.
In this context I am responsible for finding suitable projects for our different services. I would also like to mention that all my colleagues are incredibly nice and we are a great team.
9. What insights - professional and personal - have you gained in your time at emovis so far, and which ones have you especially gained as an account manager?
I have gained professional insights primarily in getting to know the individual studies and their implementation in practice as well as the entire logistics behind them. I was very impressed, for example, that we were able to vaccinate hundreds of patients against tetanus, diphtheria, pertussis and poliomyelitis (Tdap-IPV) in a very short time as part of a study.
Personally, in my professional life I have rarely experienced such a pleasant and friendly working atmosphere among the team and with the management level.
10. What do you do to maintain a work-life balance?
As I said, I start work as early as possible so that I still have enough free time in the afternoon. I try as best as I can to stick to the hours I work and also keep track of them by documenting them regularly. I also have many hobbies, such as photography, singing in the choir, gardening and baking, which I pursue after work.
11. What would you like to tell our readers at the end?
I would like to tell you something about my work-life balance, because in my free time I have a part-time job as a photographer. I've been taking pictures since I was 16 years old and my friends have a lot of pictures of them and their families that I've taken. Since 2014 I am self-employed and photograph different events like confirmations, family celebrations, weddings, but also do newborn or family shoots and much more. I just love taking pictures and the positive feedback from my customers makes me really happy.
Dear readers, thank you for your interest and we hope you enjoyed reading our interview with Dr. Hella Mühlbauer. You will find several other exciting interviews with emovis employees on our blog: Among others, we talked to Annika Schuett and Carolina Martins from Homecare Visits about the 10th anniversary of the department and the future of decentralized clinical trials (part 1 and part 2 of the interview).