PTUC to generate high quality data for our trials. About the role: This role is integral to the DM team, and it is an excellent opportunity to utilise your clinical trial data management skills in all study types, including CTIMPs, devices and multi-site studies. Being involved at all trial stages, from protocol design to database lock. The post … holder will be responsible for designing, implementing, and maintaining database systems and resources for the recording of clinical trials data, ensuring that they are compliant with appropriate regulatory requirements. They will also work closely with PTUC's statisticians to provide support to the design, monitoring, and analysis of data sets (using R). Working as a liaison between the … SQL databases (e.g., PostgreSQL.) Experience of running web servers and data servers. Desirable Expertise in using the OpenClinica (version 3 or 4) data management system Good knowledge of GCP requirements and all aspects of information governance and related legislation for electronic data capture and data base validation. Experience working in a clinical trial setting or academic environment Demonstrable More ❯
either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise … effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT). Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. Comply with company, department and industry standards (e.g. … including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). Good communications and negotiation skills, ability to work well with others globally Experience as Trial Programmer, including coordination of internal or external programmers on a given More ❯
chance to provide statistical programming solutions to HTA problems. The successful candidate will work closely with International Value & Access and HEOR teams to shape ways of working for Joint Clinical Assessment in Europe to ensure high-quality deliverables. The Senior Principal Statistical Programmer will be responsible for all statistical programming aspects of several studies, a medium to large sized … style, quality of statistical reporting & compliance with timelines. About the Role Key requirements Lead statistical programming activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study or project level. May act … including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures) Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study More ❯
Data Management Lead London Summary The Data Management Lead (DML) in pharmaceuticals Sciences is responsible for overseeing all data management activities throughout the lifecycle of clinical trials, ensuring the delivery of high-quality, reliable, and compliant clinical data. This … role involves leading data strategy development, managing timelines and deliverables. The DML ensures data collection tools, data cleaning processes, and database lock procedures are aligned with regulatory requirements (e.g. GCP, CDISC standards) and project goals. They also manage vendors and internal data teams, driving efficiency, accuracy, and innovation in clinical data handling. Key Accountabilities: Lead the development and execution … data delivery. Oversee the design, setup, and validation of clinical databases and eCRFs in alignment with study protocols and regulatory standards. Ensure all data management activities comply with GCP, internal SOPs, and industry regulations, including CDISC standards. Manage data cleaning processes, including query generation and resolution, coding, and reconciliation of third-party data sources. Act as the primary point More ❯
