Clinical Trials Management Placement Student Review

• Support trial management of global phase I, phase II and phase III oncology clinical trials. • Correspond with local teams to ensure trial specific data is up-to-date, complete, and accurate. ­• Develop and update multiple trial specific tracking systems for various trial information. • File in and manage the central Trial Master File. • Create and distribute weekly reports from CRF, IWRS and vendor management systems. • Present and provide biweekly updates at study team meetings. • Engage cross-functionally with internal teams. • Manage global vendors to ensure protocol is adhered to.

Professional Skills: From no prior experience working within clinical trials, I am now confident with multiple different clinical trial management systems such as the vault trial master file (VTMF), Case Report Form (CRF) which contains patient data and the Interactive Web Response System (IWRS) which manages drug supply. I am also confident using vendor management systems and corresponding with external vendors. Through my role I have developed understanding of clinical research, including the application of ICH Guidelines for Good Clinical Practice. I have also attended several Lunch & Learn sessions given by different business areas which has improved my understanding of the pharmaceutical industry further than what I learn through my day-to-day tasks. I have greatly improved multiple areas of computer literacy during this year at Johnson & Johnson. Working remotely has set the requirement for strong skills in communicating virtually. From almost no previous experience using online communication tools, I now have daily experience. I additionally have greatly improved my Excel skills as this is another software application that I use daily. Finally, I have learnt basic coding skills in RStudio with my mentor in the Statistical Programming and Analysis functional area. Interpersonal Skills: I regularly use skills such as attention to detail, problem solving and collaborating in teams within my role. Through working on Johnson & Johnson's Bridge to Employment scheme I have improved leadership capabilities. I have engaged in networking conversations with colleagues to improve my commercial awareness. Personal Development: Increased confidence to articulate viewpoints and ask questions.

I was given a high level of responsibility during my placement at Janssen. I was integrated as part of multiple study teams and not treated as a student, but a valued member of these teams. I was given multiple projects and tasks throughout the year and contributed to study team meetings to discuss study progress. I was given the autonomy to work on tasks and manage my workload. I was also encouraged to identify areas which I wanted to grow and develop and seek opportunities to support this.

I had a line manager who I had monthly calls to discuss my progress and objectives for the future. I had typically one colleague on each study I worked on whom I worked very closely with and who mentored me in new tasks. I was able to reach out to these contacts when I needed support or had run into problems. I was assigned a mentor based on characteristics that I identified to support my development about 1/3rd of the time through my placement. We met once a month to discuss how I could meet my development goals. There is a strong student community at Johnson&Johnson and was able to communicate to other student's for support. There are also placement leads who check in on you every 3 months to discuss how you are doing. The general attitude towards placement students at Johnson&Johnson is extremely positive and personal development and supporting the growth of others is a priority.

Student Culture: The students cohort have multiple sessions throughout the year on a variety of topics such as lunch and learns with senior business leads and sessions on skill development. We are also encouraged to lead, organise and participate in charity events for a local charity as a cohort. There are multiple employee resource groups which students are welcome to join and help run events on mental health/diversity and inclusion etc. Johnson & Johnson placement students are also welcome to join outreach initiatives with local communities such as the Bridge to Employment program which works with local schools. Company Culture: Johnson & Johnson have an amazing company culture and I felt extremely valued as an employee. Johnson & Johnson also hold regular townhalls and forums to discuss progress in your functional area which discusses new initiatives/projects and is always inspiring and exciting to hear. I was also lucky enough to talk at a forum for my functional area and discuss the experience of placement students. The J&J office has a gym, but unfortunately I was unable to use this as I worked remotely due to COVID-19.

Despite working virtually due to COVID-19 I have very much enjoyed my placement with Johnson & Johnson. I have worked with amazing study teams, with colleagues who are passionate about their work. I have been able to have amazing opportunities both in my role and outside of my role to support company values. I feel I have progressed immensely both personally and professionally. I am now much more employable in the pharmaceutical sector as I have experience and developed the necessary skills to succeed within this field. I am also more capable heading back to university with increased communication, team work and pro-activity competencies.

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Be certain on your values and motivations for yourself and your career as well as the Credo and values of Johnson & Johnson. Be aware of how these align and how your motivations would enable you to be successful within the company. In my assessment centre there was an interview, presentation and group task. Practice your presentation so that you are confident and clear when communicating and be able to answer questions on your topic.