5 of 5 Good Clinical Practice Jobs in the East of England

forefront of crafting Tables, Listings, and Figures (TLFs) for analysis purposes. Depending on the project's size and complexity, you may lead programming efforts, ensuring alignment with ICH guidelines, Good Clinical Practices, and regulatory requirements. You'll also have the opportunity to mentor fellow programmers and represent Statistical Programming in meetings with internal and external clients. Are you … using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of: SDTM and ADaM principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and More ❯

conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other … in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. More ❯

than 3 years). Extensive experience in regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements. GLP/GCP/GMP experience is preferable. Experience in supporting regulatory inspections. #J-18808-Ljbffr More ❯

you will be responsible for providing administrative support for the Product Development/QMS team to maximise quality and efficiency and ensure compliance with relevant GxP regulations (GMP, GDP, GCP and GVP). Job Interactions & Interface: This role interacts internally with key areas such as Regulatory – CMC, Clinical and Product Development, Supply Chain, Project Management, Legal and Finance. Externally … wider department as required. Qualifications and Skills: Excellent written and oral communication. Ability to work in a proactive and autonomous manner, as well as being part of a team. Good time management skills, whilst maintaining quality focus and a high level of attention to detail. Ability to create and maintain strong working relationships across the organisation and with external More ❯

within a small team. The main purpose of the role is to manage all set-up aspects of clinical trials according to Good Clinical Practice (GCP), standard operating procedures (SOPs), and trust policies. Main duties of the job Oversee the efficient and timely set up of clinical trials and workforce planning on a daily basis … Use initiative and work independently without close supervision, planning and organising own time and complex workload activity with prioritisation. Understand that all research must be conducted according to ICH-GCP, the EU Directive on Good Clinical Practice, and the Research Governance Guidelines. Person specification Qualifications/Training Postgraduate level education or equivalent experience Relevant training courses in … up, experience of staff supervision/management, and experience of working in a healthcare setting Skills Leadership Organisational Communication Knowledge Detailed knowledge of the clinical trials process and GCP guidelines/EU Directives Understanding of medical terminology Working for our organisation At East and North Hertfordshire NHS Trust, we are proud of the range of general and specialist services More ❯