1 to 6 of 6 Good Clinical Practice Jobs in the East of England

Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits more »

We are seeking a dynamic senior Study/Trial Manager (CSPM) to lead our clinical trials with precision and expertise for a period of 6 months. As a senior member of our clinical operations team, you will be responsible and accountable for the operational delivery of our clinical … of complex clinical trials from inception to completion. · Develop and manage comprehensive study timelines, budgets, and resources. · Ensure strict compliance with regulatory requirements, GCP, and ICH guidelines. · Lead cross-functional teams, including CRAs, data managers, biostatisticians, and other key stakeholders. · Monitor study progress, identifying and resolving issues to maintain … field; advanced degree (e.g., MSc, PhD, MD) preferred. · Minimum of 5-7 years of experience in clinical trial management. · In-depth knowledge of GCP, FDA regulations, and ICH guidelines. · Demonstrated ability to deliver multiple, complex studies simultaneously. · Exceptional organisational and project management skills. · Strong leadership and team management capabilities. 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 »

resources available. You should be able to demonstrate experience of successfully managing an operational service as well as having recent experience of leading in clinical or research innovation and working in collaboration across professions and services. Sound knowledge and experience of genomics within maternity or paediatric services is desirable. … focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe … Analysis, interpretation and use of information Time Management Able to react under pressure Knowledge Essential An understanding of issues surrounding research, including patient confidentiality, good clinical practice and research governance Comprehensive knowledge and understanding of NHS policy and strategy with a proven ability to translate into local more »

and demonstrate that high quality data is being collected and that the trial is being conducted according to the ethically approved protocol and ICH-GCP standards. They will also coordinate data collection and data entry and responding to everyday queries from research nursing team and study participants including coordination and … delivery of a comprehensive, high-quality service within the CRF in accordance with Trust Policies, R&D SOPs, Good Clinical Practice (GCP) and all other regulatory requirements. *To contribute to the implementation, monitoring, improving and management of the CRF's Operations, policies and SOP and support its … in touch with the contact for this role. Person Specification Qualifications Essential Science graduate or equivalent level of Knowledge and experience Desirable Recent ICH GCP Training Experience Essential Experience of working in a clinical research environment within NHS, University or pharmaceutical industry Experience of working with multi-disciplinary teams. more »

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 »