Associate Clinical Data Scientist Review

My role as Associate Clinical Data Manager lies within the pharmaceutical research and development (R&D) in the oncology group. Within a team of Global Clinical & Data Operations (GCDO) within Clinical Operations. Data Manager is an office-based role, where we are responsible for managing phase 1-4 clinical trials by ensuring that data collected is complete and of high quality. We ensure the data is collected correctly using computerised checks to review the data; it needs to meet FDA approvals. I work closely with all members of the study team which includes statisticians, programmers, and clinical scientists. As a multidisciplinary team, we ensure that the patient is the core of every task. During my ten-month period so far, I have worked on four clinical trials within oncology. Some were outsourced studies; GSK is the sponsor working with a contract research organisation (CRO). All trial activities are monitored by CROs, whereas data managers oversee and advise; simply means less direct data querying and more review and setup. The following gives an overview of some of the key responsibilities and tasks I was involved in: As a team, we ensure we collect data that will be useful to statisticians. One key responsibility I was assigned was to review the electronic case report form (eCRF). Which is a document where the clinical trial site inputs the patient’s data such as demography, regimen and consent. I reviewed this document and applied the instructions to a dummy eCRF which we call a user acceptance testing (UAT) before the site receives the finalised version, which took two days. When data is delivered, it needs to be structured by regulatory agencies’ format. We call this format the Standard Data Tabulation Model (SDTM). As a data manager, I have the full responsibility by my team to review patient’s data bi-weekly and input any issues within an SDTM log, for the CROs to directly query with the site. This involves using various computerised checks that I was trained in. I was given the responsibility to create a clinical query tracker; a shared document where our clinical team raises any concerns about patient data. Then the CROs will query their concerns with the site. I am responsible for sending out weekly updates which include metrics of the open and closed queries. My role is key as I need to ensure communication is met between both teams constantly every week to avoid delays in timelines.

During the first two weeks and months of my placement I underwent online training courses and SOPs which are standard operating procedures to help me become equipped when starting the role as a data manager. This duration aided me with understanding my roles and responsibility and the wider business I was able to quickly get stuck into the tasks and join team meetings alongside taking responsibility for some tasks for example chairing the PK meetings. There were many opportunities available for me to develop my skills which I was keen to undertake to stretch myself outside of my comfort zone and experience a job within the Pharmaceutical industry. Whilst undertaking tasks set by my manager, I was able to develop my time management skills and self confidence in my own abilities, as I challenged myself to seek information and reach out to the study team for any further guidance. Working within a multidisciplinary team of scientists, statisticians, programmers, study delivery leads and regulatory affairs I was able to develop my communication and practise my presentation skills as I chaired some meetings call mom presented journal clubs to IP students and communicated via email with study members. What excited me the most was having the opportunity to collaborate with many individuals who were very knowledgeable and had a lot of experience in the Pharmaceutical industry in meetings, decision making and in 1-1 sessions. As well as my main role as a data manager and the projects I've worked for at GSK, I also had the opportunity to become a stem ambassador.

During my ten-month period so far, I have worked on four clinical trials within oncology. Some were outsourced studies; GSK is the sponsor working with a contract research organisation (CRO). All trial activities are monitored by CROs, whereas data managers oversee and advise; simply means less direct data querying and more review and setup. The following gives an overview of some of the key responsibilities and tasks I was involved in: As a team, we ensure we collect data that will be useful to statisticians. One key responsibility I was assigned was to review the electronic case report form (eCRF). Which is a document where the clinical trial site inputs the patient’s data such as demography, regimen and consent. I reviewed this document and applied the instructions to a dummy eCRF which we call a user acceptance testing (UAT) before the site receives the finalised version, which took two days. When data is delivered, it needs to be structured by regulatory agencies’ format. We call this format the Standard Data Tabulation Model (SDTM). As a data manager, I have the full responsibility by my team to review patient’s data bi-weekly and input any issues within a SDTM log, for the CROs to directly query with the site. This involves using various computerised checks that I was trained in. I was given the responsibility to create a clinical query tracker; a shared document where our clinical team raises any concerns about patient data. Then the CROs will query their concerns with the site. I am responsible for sending out weekly updates which include metrics of the open and closed queries. My role is key as I need to ensure communication is met between both teams constantly every week to avoid delays in timelines. Data must be validated effectively so that it meets FDA requirements. I had to complete quality checks on electrocardiogram (ECG) reconciliation forms, which are a collection of electronic files containing patient’s ECG data created by our CRO from our GSK database. I had to ensure that the data was collected correctly by manually reviewing all the data using various systems. This task taught me to be more responsible, organised and independent; I organised a meeting led by myself with my manager, CROs and the vendor to discuss and solve issues I found. Data managers need to make sure that all relevant documents have been uploaded to the electronic trial master file (eTMF). The eTMF is a repository of all the documents relevant to the running of the trial, which is important for transparency with regulatory bodies. I was given the responsibility to rename files and add a set description as per guidelines to be uploaded in the electronic repository.

During my placement, I had monthly meetings with GSK mentor, which helped me develop my networking skills. I also met up with my manager on a weekly basis to answer any questions or queries I had, as well as reviewing my workload.

GlaxoSmithKline is also known as GSK; a science-led global healthcare company with a purpose: to help people do more, feel better and live longer. GSK also implements values of patient focus, transparency, respect and integrity. Everyone I met was very respectful and willing to speak to me as an industrial placement student and inform me about their role and experience at GSK. I felt very welcomed.

During my industrial placement I have developed various skills both within my role as a data manager and in off desk activities as a STEM ambassador. I am so grateful to have been given this opportunity to be part of a clinical trial at GSK and be a member of the IP cohort. Regardless of working from home currently due to COVID-19 pandemic, I was still able to achieve my aims and beyond. I was able to meet with all the team members and communicate with them on a one to one basis an understand their roles. I'm also very grateful to how welcoming the team was and willing to help me with the onboarding process. I would redo this placement year if I could !

Yes

I would fully recommend this placement as it is a great opportunity to gain an insight into the wider business alongside developing your interpersonal skills.