Company description: QA Director Audit & Inspection GCP-CDCS As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across … process improvement initiatives What we offer: Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. more »
About the role ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do … large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP. This position is multi-sponsor and supports medium and … in medicine, science, or equivalent Previous monitoring experience in medium and large -sized studies, including study start-up and close-out Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data Excellent written and verbal communication Ability to work to tight deadlines Availability to travel (domestic fly more »
processes, and standards to maximize efficiency. Support the development and implementation of a global programming ecosystem to enable successful project deliverables. Work collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting. Independently performs or oversees the production and/… QC) performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements. Participates in development of a global programming standard library to enable consistent and efficient project deliverables across portfolios … Mathematics, Computer Science or related discipline, advanced degree preferred. 10+ years (5+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting. Excellent knowledge of statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc. Oncology or infectious disease therapeutic areas and submission more »
processes, and standards to maximize efficiency. Support the development and implementation of a global programming ecosystem to enable successful project deliverables. Work collaboratively with Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting. Independently performs or oversees the production and/… QC) performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements. Participates in development of a global programming standard library to enable consistent and efficient project deliverables across portfolios … Mathematics, Computer Science or related discipline, advanced degree preferred. 10+ years (5+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting. Excellent knowledge of statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc. Oncology or infectious disease therapeutic areas and submission more »
enthusiastic, self-motivated, organised quality professional with a keen eye for detail. Some previous experience (ideally between 1 - 2 years) of working in a GCP regulated environment or in a quality environment in a clinical trial organisation is desirable. Day to day, you will oversee the Companys quality systems more »
Cambridge University Hospital NHS Foundation Trust
at Cambridge University Hospitals. The Data and AI Research Governance Coordinator is responsible for providing expert advice for a portfolio of research involving NHS clinical informatics and AI across a wide range of specialties, throughout the life course of the research project. The post holder will assist with the … initiative. We are an inclusive department and offer flexible working arrangements. Main duties of the job This post does not involve directly working with clinical data. The role holder will provide advice and support to researchers in all aspects of data and AI research governance, including submitting applications to … Knowledge and understanding of research funding streams and award bodies Qualifications Essential Educated to degree level or equivalent experience Desirable Post graduate research qualification GCP Trained Skills Essential Excellent communication skills Excellent organisational and planning skills Excellent interpersonal skills including the ability to build working relationships with department colleagues, Trust more »
