GSK is 1st in Science & Research Top 100 Undergraduate Employers 2020 - 2021
- GSK
- Placement Year (10 Months+)
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.
