Clinical Trial Specialist Apprentice Review

I work in the study management function within Early Oncology Study Operations. At the moment I work on two clinical trials in the role of Global Study Associate - an inhouse Non-Small Cell Lung Cancer trial and an outsourced Ovarian Cancer study that is currently in the close-out phase. My role is office based and involves meetings with various functions and countries on the trial. The study management team operationally manage the trial from a global level. I have regular day to day tasks that I perform as part of the GSA role, as well as other adhoc/tasks and projects I am/have been involved in to increase my understanding of our trials. Some of my regular tasks include: - Coordinating the quarterly QC of the TMF (trial master file) for all functions - Training colleagues on the TMF QC process - Performing the study management TMF QC quarterly - Sending weekly patient recruitment updates for each of the modules on our trial - Presenting metrics and TMF updates and weekly/biweekly and monthly trial team meetings - Sending a bi-monthly study newsletter (with any trial updates) to the investigators and hospital site staff - Maintaining our completeness and timeliness levels of the TMF - Keeping our study team list up to date and providing team members with system accesses - Attend and contribute at the following meetings: Study Management meeting, Study Team meeting, SMM Meeting - Shadowing meetings between our Global Study Managers and Local Study Managers for the countries on our study (i.e. USA, Japan, Spain) - Update our study TMF plan and Communication plan Adhoc tasks I have done: - Answer questions on the study Q&A log for a month (this is where CRAs and site staff can ask us questions regarding patient eligibility/the study protocol etc) - Updating an informed consent form (ICF) for one of the treatment modules on our study, using our system called ANGEL - Patient allocation - allocating patients to their treatment cohorts. This involved using one of our systems called entimICE

I have learnt so many new skills since starting my apprenticeship. From basic 'office' skills such as using Outlook, Microsoft Teams and Excel to using different clinical systems (such as Veeva Vault, ANGEL, RAVE and entimICE). I also feel my communication skills have greatly improved due to always communicating with a wide range of people and contributing during team meetings. Aside from this, my degree has greatly improved my essay writing skills, as well as time management and of course, my understanding of different Bioscience topics!

I really enjoy my programme, and always have done since joining over a year and half ago. I seem to enjoy my programme even more as it progresses as I get more familiar with the role and have a better balance of working and degree work. I continue to learn new things on a weekly basis which makes the programme engaging.

There is some structure to the programme however, there has been some uncertainty around our rotations across the business which has at times been unsettling as this involves (in some cases) working at different sites - which aren't always nearby. It would be more organised if we had a more solid idea of where we will be working and when. To an extent however, not having a really rigid structure has been a positive part of the programme as it leaves room to get involved in areas you're interested in. For example, the team members on my study often find things for me to be involved in as and when they come up and these have all been really beneficial to my learning.

I receive a great deal of support from my employer. I have weekly 1-2-1 meetings with my manager where I can discuss any concerns and feel I would be supported if I was to do so. I have also had a mentor since joining who has been a really great help and offered support where required. The team as a whole have always expressed that they are happy to help with any questions and I have never felt like I have nowhere to turn to if I get stuck - even while working from home during the pandemic.

I feel there is limited support from University of Kent. Some tutors are very responsive and helpful while others either take a very long time to reply or fail to reply at all. Generally I find that the academics are helpful if you have a degree question but if it is a more general question about your degree, it is often a struggle to get help from Kent.

Due to my degree being a bioscience degree and my job being more study/project management my degree generally doesn't directly help me to perform better in my role. It does however increase my understanding of the industry as a whole and some of the background information of our trial. Sometimes (though not always regularly) I am able to gear my essays towards my work and Kent do try wherever possible to link our assignments to the workplace. We have only done one clinical module on our degree so far but there are more to come so I feel that as the degree progresses it will become more relevant to my role.

We have lots of opportunities to get involved in other activities for example, I am a member of the Apprentice Committee, which allows me to get involved in apprentice activities with apprentices on other schemes. We also have AZinspire who hold industry talks on different subject areas, as well as networking events, though I haven't attended any of these myself. When we were in the office, my team were very social and often organised social events which everybody can get involved in.

Yes

AstraZeneca have been a brilliant company to start my career in. I feel very supported and encouraged. I have learned and continue to learn so much, always building my experience, which is essential being a young person entering the world of work. There are so many opportunities at AZ and knowledge sharing/being involved in new projects is supported.

I would say be yourself. I think as young professionals entering the world of work we have been taught in school to always maintain the upmost professionalism, and this is important, but it is ok to be yourself too! Research the role you are applying for to make sure you are able to answer interview questions. And finally, be willing to learn as that is a huge part of being an apprentice.