26 to 50 of 58 Good Clinical Practice Jobs in the UK

a positive, results oriented work environment, modeling teamwork and communicating with team members in an open, balanced, and objective manner. Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices. Role requirements: Proven significant work experience in a CRO/Pharma setting (operational or technical). Proven experience in clinical trial systems (e.g., CTMS, EDC … RTSM) with detailed understanding of requirements gathering, documentation, configuration, and integrations. Knowledge in clinical research industry, including detailed understanding of clinical technology, design, and system requirements. Proven record of influencing a team to deliver according to a schedule. Experience of mentoring or providing work direction to staff. Ability to motivate and work effectively with virtual teams within different … use of data standards in clinical trial environment. Client focused (internal and external) and demonstrating an ability to create and maintain trust with clients. Knowledgeable in ICH and GCP regulations in relevant geographies. A little about us: Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program. We offer competitive financial packages, training, and development. Expect 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 ❯

IDAR) organization. The Principal Engineer Digital Health Enablement is responsible for shaping the interfaces between partners, system and process for capabilities administered by Enabling Analytics & System Excellence EASE within Clinical Trial Management Solutions (CTM Solutions) or Investigator & Patient Solutions (I&PS). • The Principal Engineer Digital Health Enablement within CTM Solutions will oversee end to end system planning, administration … oversight and related processes for capabilities supporting clinical trial document management/TMF, study management and oversight. • The Principal Engineer Digital Health Enablement will oversee end to end system planning, administration, oversight and related processes for capabilities supporting patient engagement, site staff enablement, clinical staff training. This includes driving customer enablement and innovative solutions for the supported capabilities … leading inspection-ready practices for the supported capabilities, with a focus on delivering measurable value for stakeholders. • Lead change management efforts, promoting the adoption of new tools and ensuring clinical trial teams are well-equipped to use them effectively. • Remaining connected as a primary point of contact with stakeholders, functional area points of contact and subject matter expert frameworks. More ❯

improvement of the Quality System, inspection management, regulatory intelligence activities, SOP and WP management, and project liaison activities. In close collaboration with the Head of Global Quality Management of GCP, CSV & GVP, Senior Director Global Quality Management, and the CSV Audit Lead, the candidate will: Possess a degree in natural sciences or equivalent business experience. Have several years of relevant … experience in IT, pharmaceutical, medical devices industries, or regulatory authorities, including Quality Assurance, CSV, Data Integrity, Pharmacovigilance, and Clinical Development. Be an expert in relevant regulations and guidance documents. Have experience as a Lead Auditor for internal and external audits. Be experienced in GxP-related CSV audits and inspections. Understand computerised systems in GxP environments, including software validation and More ❯

programming activities for large/pivotal studies or several studies, or act as a Lead/Programmer for a small to medium-sized project in phase I to IV clinical studies. Coordinate activities of all programmers, mentor team members, and make programming decisions at study or project level. Build and maintain effective cross-functional relationships, discussing deliverables, timelines, scope … Your Experience BA/BS/MS or equivalent in statistics, computer science, mathematics, life sciences, or related field. Ideally 5+ years of experience in a programming role supporting clinical trials or in the pharmaceutical … industry. Advanced SAS skills and experience in developing and validating deliverables. Experience with statistical analysis plans and programming specifications. Knowledge of industry standards like CDISC and regulatory requirements (e.g., GCP). Strong communication and negotiation skills, with the ability to work globally. Experience as Trial Programmer and coordinating internal/external programmers. Why Novartis Helping people with disease takes more More ❯

and Requirements: Degree in Computer Science or another relevant field. Experience in SAS programming within the pharmaceutical industry. Understanding of clinical trial design and regulatory submissions. Familiarity with GCP and regulatory requirements. Knowledge of SDTM and ADaM CDISC standards. If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com More ❯

and Medicines Administration (ePMA) system across the Trust. In the absence of the Digital Lead Pharmacist, will be deputised for the daily operational management of the ePMA and Pharmacy Clinical Informatics team by co-ordinating with team members, Clinical Stakeholders, pharmacy, IT and other relevant parties to prioritise the risk management, maintenance, implementation and delivery of clinical … the quality of patient care and to promote evidence based, cost-effective prescribing, in line with departmental procedures. To maintain own training in Good Clinical Practice (GCP) to be able to fulfil requirements for providing pharmacy input to system configuration and developments. See Job Description attached. Job description Job responsibilities To be responsible for leading the Projects … the quality of patient care and to promote evidence based, cost-effective prescribing, in line with departmental procedures. To maintain own training in Good Clinical Practice (GCP) to be able to fulfil requirements for providing pharmacy input to system configuration and developments. See Job Description attached. Person Specification Qualifications Essential Masters degree in Pharmacy MPharm or equivalent More ❯

Job summary Are you ready to drive transformative change in pharmacy practice through cutting-edge technology and innovative informatics? In this role you will play a crucial role in shaping the future of medication management and patient care. You'll leverage your expertise to optimize electronic prescribing and medication administration (ePMA) systems, ensuring seamless integration within clinical workflows. … and Medicines Administration (ePMA) system across the Trust. In the absence of the Digital Lead Pharmacist, will be deputised for the daily operational management of the ePMA and Pharmacy Clinical Informatics team by co-ordinating with team members, Clinical Stakeholders, pharmacy, IT and other relevant parties to prioritise the risk management, maintenance, implementation and delivery of clinical … the quality of patient care and to promote evidence based, cost-effective prescribing, in line with departmental procedures. To maintain own training in Good Clinical Practice (GCP) to be able to fulfil requirements for providing pharmacy input to system configuration and developments. See Job Description attached. Person Specification Qualifications Essential Masters degree in Pharmacy MPharm or equivalent More ❯

holder will lead on project planning, risk assessment, and coordination of multidisciplinary teams. They will also support broader University partnership activities as required. Team members will include: amongst others, Clinical research fellows, Study nurses, Laboratory technicians, Bioinformaticians, Project Managers and Post-doctoral researchers. This role requires a proactive, organised, and adaptable individual with strong project management, communication, and leadership … acquired the necessary professional knowledge and management skills in a similar or number of different specialist roles. A2 Working knowledge of Principles of Good Clinical Practice (GCP), General Data Protection Regulation (GDPR) and research governance framework legislation. A3. A working knowledge of public sector policies and procedures, specifically understanding of the contractual, legal and financial matters in … implement new SOPs and processes to enhance efficiency and ensure compliance. C14. Practical application and understanding of data protection, GDPR and other statutory requirements and professional guidelines, including ICH GCP Guidelines Desirable: D1. Flexibility to work across multiple time zones for global collaboration, to ensure seamless coordination of meetings across different regions. Experience Essential: E1. Significant project or programme management More ❯

Overview 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, we help to accelerate the development of drugs and devices that save … successfully performing the role of Statistical Programmer, preferably in the clinical research industry Good understanding of global clinical trial practices, procedures, methodologies and regulatory requirements (e.g., GCP, ICH) Experience with R programming is essential Good working knowledge of the types of risks associated with a study and the impact on key parameters, such as study timelines … Strong working knowledge of statistics and statistical software packages Strong SAS programming skills Good working knowledge of statistical concepts Strong working knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation Strong working knowledge of the development and use of standard programs and macros Ability to critically review data and implement corrective action steps effectively More ❯

more exclusive features. Position Overview The Principal Statistical Programmer works independently with minimal supervision, tracking progress and providing expert technical support to team members. The role involves working on clinical development programs across different therapeutic areas, overseeing CRO programmers, and ensuring high-quality data summaries. Responsibilities include implementing reporting and analysis activities for clinical trials, with a focus … validating SAS (and potentially R) programs. Program outputs for HTA dossiers, publications, and exploratory purposes. Understand and process data structures (CDISC or non-CDISC). Follow regulatory guidelines, including good clinical practice and electronic submissions. Contribute to standards creation, maintenance, documentation, and validation. Review and author data transfer specifications for external vendors. Collaborate with internal and external … and work instructions related to statistical programming. Qualifications Bachelor's degree in computer science, data science, mathematics, or statistics. 7+ years of experience as a Statistical Programmer in a clinical development environment. Expertise in SAS programming and clinical statistical procedures. Extensive experience with CDISC standards and regulatory requirements. Experience supporting regulatory submissions and HTA dossiers is a plus. More ❯

Overview As a Principal Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What you will be doing: Develop, review, document and perform validation of SAS programs and macros. Support the development of data repositories, pooling multiple studies Create standard reports in different output formats Automate programming tasks … overengineering software. Is able to demonstrate leadership in development of general purpose tools. Is creative, brings ideas to the table and can perform well when given creative freedom. Display good communication skills, is able … to explain ideas and can also listen well to ideas from others, can be self-critical. Thorough knowledge of and experience with CDISC standards is desired. Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development. Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and More ❯

full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Within Enabling Business Information Solutions (EBIS), the Clinical Trial Management Solutions business is recruiting for a Trial Master File (TMF) Analyst to join our Trial Master File (TMF) Center of Excellence (COE) team. The position may be … Qualifications Education and Experience Requirements Education : A bachelor’s degree is required, preferably in health, science, or information technology. Experience : At least 3 years in the pharmaceutical industry or clinical trials. Candidates should have strong technical expertise, with proficiency in electronic records systems (particularly eTMF), IT tools, data warehouses, and, ideally, database administration. Familiarity with emerging technologies such as … RPA), Machine Learning (ML), and Artificial Intelligence (AI) is a plus. An understanding of TMF content management, clinical trial conduct, drug development processes, and regulatory standards (ICH/GCP) is advantageous. Experience with audits, inspections, and implementing quality metrics to support decision-making is highly desirable. Good communication, problem-solving, and organizational skills are crucial, along with the More ❯

are required to declare this in their supporting statement. Job overview We are seeking an enthusiastic and diligent researcher to facilitate a mixed-method sub study within a cancer clinical trial. The RADIUS Research Facilitator will be responsible for coordinating the qualitative interview component of the RADIUS study. The RADIUS study will explore how people with the blood cancer … multiple myeloma experience receiving complex information about the genetics of their myeloma and its response to treatment as part of the RADAR clinical trial. The role primarily involves recruitment of people with myeloma enrolled in RADAR for the RADIUS qualitative study and carrying out qualitative interviews. The post holder will be based between UCLH and UCL, working closely with … or social science, arts & humanities or psychology. Use of statistical and/or qualitative data management software. Knowledge of cancer and cancer service provision in England. Knowledge of ICH GCP guidelines. Experience Experience of interpreting complex information. Experience of conducting research. Experience of patient involvement/engagement, and involving patients in research. Experience of setting up/conducting research in More ❯

As a Manager, Site Engagement Liaison, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The Site Engagement Liaison Manager is a field based expert who supports the conduct and the patient recruitment of the client global clinical trials at investigative sites, through local and relational support. What you will … activities such as accompanying the CRO CRA during site visits. This to ensure high quality conduct and execution of the clinical trials according to the protocol and ICH GCP and local regulatory requirements. Closely work together with the Medical Affairs colleagues, eg the MSLs to ensure optimal synergies in the respective site contacts and support. Optimize site engagement for … for travel nationally and occasional international travel. Experience in global clinical trials is a plus Prior experience in Neurology, Auto-immune and rare disease background Knowledge of ICH-GCP and other applicable legislation Ability to quickly understand complex neurological disease areas, treatments and clinical development plans Understand the healthcare therapeutic landscape, patient pathways and investigative sites Excellent communication More ❯

Fixed-term for 3 years in the first instance Hours: Full time About the role We have an exciting opportunity for a Senior Data Manager to join the Oncology Clinical Trials Office (OCTO). OCTO, part of the University of Oxford's Department of Oncology, is a leader in early cancer detection, precision prevention and therapy trials, delivering groundbreaking … clinical research. As the Senior Data Manager, you will be responsible for ensuring that data collection systems and data management activities are appropriately designed, implemented, maintained, or developed to support the collection of high-quality clinical trial data sets for analysis, publication, and, where appropriate, future data sharing. Data from multiple sources needs to be integrated in an … data management and information governance within clinical trials, including CTIMPs, in a sponsor organisation. You will have experience of implementing approaches to ensure compliance with high standards of GCP, the requirements of UK clinical trials and data protection legislation, and will have experience of developing and delivering training in relation to data management and integrity. You will have More ❯

providing aseptically prepared clinical trial doses for patients across different specialities within the Trust and maintaining up-to-date documentation according to Good Clinical Practice (GCP). The main role of this post is to supervise and manage the day-to-day service provided by CTASU and to ensure that aseptic preparation of medicines is run … working knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20EC), Human Medicines (EU Exit) Regulations 2019 and the International Conference on Harmonisation GCP Guideline (ICH GCP), as applicable to the dispensing of Investigational Medicinal Products for clinical trials or other products e.g. NIMPs, physiological compounds given to study subjects. To facilitate NHS … competency frameworks where appropriate. Clinical Trials To ensure all CTASU staff are in compliance with relevant standards for the operation and management of Clinical Trials, including ICH-GCP and GMP. To ensure all members of the CTASU staff have appropriate ICH-GCP training. To work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and EU More ❯

talk with your recruiter to learn more. Base pay range Product Manager - Health Tech Company Join Us in Revolutionising Healthcare! Are you passionate about leveraging technology for the greater good? Here's your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey … years of product management experience in healthcare technology Working knowledge of healthcare data standards, particularly FHIR Product analytics, UI/UX feedback loops, and process optimization Experience with clinical workflows and healthcare IT systems Strong analytical and problem-solving skills Excellent communication and stakeholder management abilities Bachelors degree in a relevant field Previous product management training (Pragmatic Marketing, Design … etc.) Preferred Experience in API-based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and offer a competitive compensation package. Cutting-Edge Technology More ❯

programs in drug lifecycle management. They oversee all aspects of programming, quality, and regulatory compliance, ensuring efficient execution and high-quality results. Responsibilities Lead statistical programming activities for multiple clinical trials within a program or indication/disease area, with experience in areas such as Immunology, Cardiovascular & Metabolic Diseases, and Neuroscience. Coordinate activities of internal/external programmers, make … software (e.g., SAS/R) and industry standards (e.g., CDISC, eCTD, Define.xml). Represent SP in audits, inspections, Health Authority meetings, and external conferences. Experience & Qualifications Deep understanding of clinical trial methodology, regulatory requirements, and GCP. BS/MS in life sciences, computer science, statistics, mathematics, or related field; fluency in English. Early development experience, preferably in Oncology. Proven 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 ❯

and Laboratory Buyer to join our team and source, negotiate, purchase and manage the supply of essential materials and equipment for the facilities department, including both laboratory research and clinical operations. This role involves working closely with the Head of Procurement to ensure that the right equipment is acquired with cost, time efficiency and in compliance with all regulatory … standards. This role offers the opportunity to work in a highly collaborative, fast-paced environment, supporting cutting-edge research whilst playing a critical role in ensuring that laboratory and clinical teams have access to the resources they need for successful project execution. Key Responsibilities: Sourcing & Procurement: Identify, evaluate, and procure high-quality lab and clinical equipment. Obtain quotes … Experience working with laboratory reagents, consumables, equipment, and clinical trial supplies is highly preferred. Knowledge of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and regulatory requirements related to procurement in scientific settings. Desirable Skills, Qualifications & Experience: Experience with procurement software, ERP systems, and inventory management tools is desirable. Educated to MSc or equivalent More ❯

tasks and responsibilities System administration tasks such as setting up user access, data extracts and archiving. Designing eCRF screens Assisting as directed in aspects of design and testing of clinical study databases Maintain own training file Responsible for ensuring that work is conducted in accordance with SOPs and the principles of Good Clinical Practice Undertake other … overtime as is reasonably required to ensure the smooth running of the department. Qualifications and experience required for competent performance IT or numerate degree and/or relevant experience Good organisational skills Ability to work to deadlines whilst maintaining quality standards Effective oral and written communication skills Attention to detail and the ability to multitask #J-18808-Ljbffr More ❯

Magentus products and services have been at the forefront of delivering health technology for more than 30 years, offering deep expertise across clinical systems, health informatics and practice management. Across pathology, radiology, oncology, maternity, and practice management, we are connecting the health ecosystem and transforming digital healthcare at scale. Driven by our dedicated teams across the globe … standards Assists with pre-sales activities The position may require on-site working across multiple implementation sites in the United Kingdom. Experience: Bachelors Degree in Biomedical Science/relevant Clinical Field or Information Technology field PRINCE2 or APMG qualifications an advantage Change Management qualification will be highly regarded Proven work experience as a Business Analyst or similar in health … of Visio or equivalent for process mapping Use of laboratory information management systems A sound understanding of the professional, ethical and legal requirements that underpin the health informatics environment Good understanding of laboratory Health and Safety, CPA, MHRA EU Blood Directive and MHRA Good Clinical Practice for Laboratories and other relevant regulations and standards Ability to More ❯

experience of administrative or project management in science or healthcare having written scientific reports and conveying complex issues in an easily understood way. Having worked in research studies or clinical trials with a knowledge and understanding of good clinical practice and research governance framework would be an advantage. The HDScI project, coordinated through UCLH BRC, NHS … of Cambridge, and part of a larger international collaboration, and is based in the UCLH BRC. The postholder will be a member of the multidisciplinary HDScI team, which includes clinical bioinformaticians, experts in statistical genomics, blood cell immunogenicity and randomised controlled trials, clinical haematologists caring for patients with inherited anaemias, and researchers in Artificial Intelligence & Machine Learning (AI … class support services including critical care, imaging, nuclear medicine and pathology. We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040. For further details/informal visits contact 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 ❯