The Study Data Manager works within Clinical Operations of Pharma R&D and is a core member of the study team. They are responsible for ensuring a high level of data integrity in all the data that is generated from a clinical trial. This includes making sure the data meets the following ALCOA CCEA criteria. Data Managers work with LDMs to oversee the activities of Data Processors s, who carry out some of the more technical data-related tasks. Data managers also work with all members of the study tea, (Statistics, Programming, Medical Monitors, Study Managers etc.) to ensure data from the clinical trial site(s) is flowing to all the areas of the company it needs to in the most appropriate format. There is no standard day - leading meetings with various stakeholders, data reconciliation work, presenting to clinical study sites etc.
I was responsible for data cleaning activities on several oncology clinical trials. This includes everything from reviewing incoming data in the data capture system to reconciling the lab samples. I attended various meetings such as central study team meetings where I met with everyone involved in the study and listened to their updates and provided my own. as well as meeting with my own team to divide responsibilities.
Working within the engineering team responsible for the upkeep and improvement of production lines as well as being partly based within the Overall Equipment Effectiveness (OEE) team. The role involved daily collation and analysis of OEE data followed by presentation of this data to representatives from various departments. Actions were then taken by the appropriate team based on data presented. Attendance of morning meetings with the team to set out key issues for the day and to update on progress of ongoing work. Most days would include the creation, presentation, management and implementation of changes and required documentation in some form, this would involve discussions with relevant members of the engineering team for the change as well as other functions within the company and occasionally discussions with the Original equipment manufacturer (OEM) or other external suppliers. Enterprise resource planning (ERP) software would be used most days to track projects and update. Each week project meetings would be had with the OEM as well as internally within the engineering team to track progress and plan future projects, these often influenced what work would be undertaken within the following week. The use of excel, PowerApps or PowerBI was also required most weeks to trend data or create tools for both engineering and production departments.
I work in cross-functional teams on a variety of projects related to digital initiatives. On a day to day basis this involves meetings and check ins with core team members to update each other on progress, taking part in digital councils sharing experiments that happen across our global sites. The aim is to identify high value and scalable technological use cases so that people's lives are made easier, safer and bring business value.
My role is acting as a support to the Plant Engineer assigned to a specific area of site. This involves fire-fighting activities to ensure manufacturing can continue. This includes carrying out Root Cause Analysis to solve problems and writing plant modifications when equipment needs to be changed. I attend daily meetings with cross-functional teams to coordinate production and plan in preventative maintenance activities.
• Co-ordinations of notifications with the SAP system. • Continuous communication with global markets. • Attending and driving meetings in cross functional teams. • Lifecycle management of packs. • Creation of new artworks and components. • Managing changes to pack bill of materials.
Process engineering is about developing and optimising a process which is used to manufacture a product. Working within R&D consumer healthcare, I had the opportunity to understand products such as toothpaste and denture care products and their manufacturing processes. Day to day, my role involved working on engineering documentation such as risk assessments and manufacturing instructions. Due to the pandemic, my opportunity to carry out my own research project was delayed and shortened however the role also involves planning and carrying out a research project which aids the team's understanding of the products we make.
On a day-to-day basis my daily tasks and interactions would vary significantly. Throughout my placement I have been involved in a wide range of activities which include but aren't limited to: - Reviewing key clinical trial documents, an example of a document I have reviewed would be the protocol. - Maintenance of the electronic Trial Master File. - Follow-up on resolution of open queries, this could be internally or externally. - Ensure that the delivery of the study is to plan. Therefore, I would be involved in managing site start-up activities, oversight of clinical vendor performance and oversight of study team activities.
My day-to-day role was to conduct research towards ongoing medicinal chemistry projects within GSK. It involved 90% lab based working once the planning and organisation around work places within COVID was sorted. I would spend my entire day at work in a lab planning reactions and synthetic pathways before conducting them. My role was very much to be a part of a team effort towards thinking of new and innovative target molecules and routes to them.
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.
Due to COVID I was based at home so my role involved emailing and meeting external partners to organise research and researching literature for future laboratory experiments. When I was in the lab I was making solutions, testing them and taking photos, as well as writing up a lot of data. Then I would present my data to the project team and tell them the importance and relevance of my work to the wider project.
I undertook my placement in the QA Validation department at Worthing site. As part of quality validation, I was specifically responsible for leading and supporting the validation and life-cycle maintenance of the site’s analytical equipment, ensuring these suitably meet the site, GSK and regulatory requirements. I contribute to a larger QA Validation team and am in coordination with, validation, automation, engineering and production with the opportunity to develop a network with these teams.
I work in a cross functional team to provide regulatory support on projects. My role involves liasing with local teams in different markets and different manufacturing site to devise a regulatory strategy. I also author and review regulatory documents then compile these documents into a regulatory dossier, which get submitted to health authorities. My role also involves using regulatory systems to track and archive information.
I manage a large team of designers who work for a 3rd party agency that GSK outsources design and marketing work to. On a daily basis, this means meeting with several team members to discuss the projects they're working on, any issues that have arisen with these, and how I can help to make the project easier in terms of communication. This also means regular interaction with many GSK stakeholders who use the team for their marketing work
My role involved testing different API's using a variation of analytical techniques. I'm also involved in projects and I'm a part of the weekly cross-labs communications team. I lead daily meetings and get involved in different continuous improvement ideas. I also support the creation of stability data tables, which contributes to the annual reports and PPRs.
I was working in Pharmaceutical Microbiology within Research and Development as part of the Chemistry Manufacturing and Controls Analytical department. My role was aligned to the development of non-sterile and sterile dosage forms for clinical and commercial supply. The role is highly practical based where I carried out a range of microbiological techniques to support the operation of the non-sterile secondary pilot plant and the development of new drugs. My main job purpose was to provide the appropriate microbiological support for product development and supply projects. This support has to be performed in accordance with applicable standards of current good manufacturing practice and safety. Some of my responsibilities included performing routine environmental monitoring for the pilot plant (i.e. water testing), performing routine microbiological assays to validate new and existing methods or procedures as well as providing technical support for team testing requirements (i.e. culture work and microbial identification procedures).