1 to 25 of 40 Good Clinical Practice Jobs in the UK excluding London

relevant experience.• BA/BS with 10+ years’ relevant experience.• Extensive drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research or related medical/healthcare environment.• Extensive experience in drug safety signal detection, benefit-risk evaluation, and authoring drug safety risk management plans … oversight.Knowledge & Other Requirements• Recognized expert in PV, regulations, signal detection, clinical trials and clinical development.• Expert knowledge of the drug development process, GCP and GVP, including worldwide PV regulations and their application to safety science activities (signal detection,clinical trials and clinical development).• Expert knowledge more »

implement comprehensive quality management strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g. FDA, EMA, etc.) and industry standards (e.g. GMP, GDP, GCP). Provide leadership and direction to the quality assurance and quality control teams, fostering a culture of quality excellence, accountability, and continuous improvement. Establish and more »

Assurance department. - Knowledge of GxP and Quality related regulations and standards within the Pharmaceutical/Medical Device industry. - Familiarity with ISO 9001, ISO 13485, GCP is essential. - Knowledge of ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor would be beneficial. Interested or know someone who might 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 »

Job summary This is an exciting opportunity for a highly driven individual to participate in the development and delivery of the Radiopharmacy quality and clinical service from our state-of-the- art facility at Royal Liverpool University Hospital. The post-holder will be undertake quality assurance and quality control … the Quality Assurance team. The Radiopharmacy at LUHFT is designed to deliver wide range of radiopharmaceuticals for imaging, therapy and investigational medicinal products for clinical trials as well as blood labelling suite. As Senior QA Officer you will help ensure the Radiopharmacy complies with all relevant regulations. You will … knowledge of IRR17 Good practical knowledge or IR(ME)R 2017 regulation Good practical knowledge of Good Clinical Practice (GCP) regulation Good practical knowledge of Radiopharmacy preparation Skills Essential Good verbal skills Good written communication skills Logical thought processes Ability to work more »

Job summary As a member of the Clinical Trials team, you will work closely with other members of the team to ensure that Christie patients have access the latest development of oncology/haematology investigational medicines. The Pharmacy Department are also supporting the large-scale collaborative project alongside several … ensure activities within the pharmacy department are managed in accordance with the International Conference of Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good manufacturing Practice (GMP), the Research Governance Framework for Health & Community Care (2001) and the Medicines for Human Use (Clinical Trials) Regulations … IVRS/IWRS for ordering, acknowledging orders. 4. Dispensing and preparation of medicines both IV and oral clinical trials in accordance with ICH GCP and study specific sops. 5. To provide support to other pharmacy staff in the dispensing of complex clinical trials. 6. Use computer-based data more »

Senior Clinical Biochemist STATUS: Full Time LOCATION: Onsite in Yorkshire, England DEPARTMENT: Laboratory SCHEDULE: Tuesday to Saturday; Day Shift SUMMARY As a seasoned Scientist IV in Clinical Biochemistry, you will play a vital role within our Laboratory team. … Your responsibilities encompass the meticulous analysis of clinical samples across automated and manual platforms, adhering strictly to Good Clinical Practice (GCP) standards. Joining our esteemed international organization offers more than just a job — it's an opportunity for professional growth and development. Supported by visionary leadership … empowering you to shape our organization and chart your career trajectory. ATTRIBUTES: • BSc in Biomedical Sciences or equivalent. • Minimum of 6 years' experience in clinical biochemistry. • Proven expertise and proficiency in assays/platforms within the laboratory setting. KEY RESPONSIBILITIES Analysis: Conduct thorough analysis of clinical trial samples more »

Please see the following for the qualifications and skills we seek for this role.Education & Experience MD/Pharm D or other advanced degree in clinical sciences with significant experience working in drug safety/PV or a related field in the biopharma industry, clinical research, health administration, health … policy, or academic or subspeciality medicine. Clinical experience is preferred.Knowledge & Other Requirements Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development).In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies.Strong knowledge of statistical methods used in PV.Proven abilities to make significant contributions to Patient Safety (PS) strategic planning and lead significant process improvements in PS.Exceptional interpersonal more »

only) pathology along with skin pathology. The medical establishment is made up of 10 consultant Histopathologists, with junior support from the deanery rotation and clinical fellow post. The appointee will be based at The Christie and together with colleagues already in post and will provide senior input to all … and out-patients within the hospital, as well as reviewing pathological materials from other hospitals in the North West for cancer patients referred by clinical, surgical, and medical oncologists. The GM-HCDP service (Lymphoma) also receives diagnostic case material from GM Trust and in-house generated samples, with plans … for further onboarding of external GM Trusts. Clinical reporting involves the use of both the local LIMS (TDHC) and the HODS regional LIMS haemato-pathology platform. It is important to note that all neoplastic myeloid pathology is reported elsewhere, so participation in reporting these samples is not required. There more »

exciting and growing Biotechnology company based in Oxford and am assisting them in a search for an Associate DIrector of Clinical Quality Assurance (GCP). The successful candidate will be reporting directly to the Head of QA and spearhead all activities related to GCP. Main Duties and Responsibilities include … Ensuring changes in GCP practices are communicated, adopted and implemented throughout the organisation by maintaining current knowledge of local and international regulations To create/author/approve or input into SOPs and policies for those relating to GCP activities To provide GCP training for staff including the preparation of … and delivery of training. To include onboarding/induction training and refresher training To take a lead role on behalf of QA on all GCP investigations including serious breaches and Urgent Safety Measures and to communicate these effectively within the organisation and escalation to the senior leadership team To represent more »

Locum Clinical Research Nurse (Nights only) Thursday, December 14, 2023 Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we helpbiotech and pharma customers save precious time and … patients. As a growing and successful business, we employ more than 1,300talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we … priorityat all times Perform study related procedures such as cannulation, venepuncture, telemetry, holters, vital signs, ECGs, collection of blood samples., in accordance with ICH-GCP Utilise nursing assessment skills to support general well-being of study participants and potential adverse events. Document adverse events and take appropriate action as needed more »

bioanalytical studies. 3. A working knowledge and practical experience using LC-MS/MS. Key Words: Small Molecule | Study Manager | Team Lead | Bioanalysis | GLP | GCP | Method Development | Validation | Sample Analysis | Regulatory Compliance | LC-MS/MS Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by more »

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 »

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 more than 20 therapeutic areas. With over … Fortrea is transforming drug and device development for partners and patients across the globe. Job overview: Provides strategic direction and oversight of Quality Assurance GCP Audit and Inspection operations and assures that audit program aligns with global RCQA strategies. Oversees external sponsor and inspectorate evaluations assuring follow up on trends … drive strategic business process improvement initiatives 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 »

inclusive of sample preparation, data acquisition and processing, and generation of development reports. ATTRIBUTES: A minimum of 3 years of study management experience in clinical and/or preclinical studies Strong background knowledge of … large molecule analysis in support of PK and PD studies. Experience working in a regulatory environment, managing studies that are compliant with GLP/GCP Experience in a client facing role with the ability to provide high level advice and guidance to clients Non-Smoker: due to the nature of more »

debilitating disease areas. Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. Job Purpose Lead all Clinical Data Management (CDM) lifecycle activities from protocol inception to database delivery for numerous global studies via oversight of multiple vendors and internal/external … database locks. Participates in Service Provider selection, evaluation and management, including reviewing and providing input to scope of work. Coordinates user acceptance testing for clinical databases. Contributes to global and sub functional working groups and initiatives. Responsibilities Responsible for delivery of clinical global study databases and specific study … is an essential part of the position Working as the sole Data Manager within the Team Key skills and experience In depth knowledge of GCP and current legislation. Working knowledge of Medidata Rave ( desirable but not essential) and IBM databases Experience of delivering global clinical studies across different phases more »

Biotech companies, are hiring a Senior Statistician to join their growing team. The role Lead and manage customer projects ensuring high-quality deliverables Analyse clinical trial data and real-world data Support HTA submissions Mentor junior colleagues Requirements 2+ years’ experience as a Statistician Industry experience, ideally working in … in the UK without needing visa sponsorship. Keywords: HTA, health technology assessment, statistician, biostatistician, ITC, indirect treatment comparison, NMA, network meta-analysis, ICH/GCP, SAS programming, R programming more »

centre for children's health research with the goal of giving all children and young people the opportunity to participate in, and benefit from, clinical research. The Clinical Research Division works with our clinicians, academia, and industry to invent, develop, and test new treatments for children and young … Premier MRI scanner. The post holder will be required to work as part of a multi-disciplinary team and deliver high-quality research and clinical imaging in the Cross-Sectional service for a variety of paediatric and adult presentations. The post holder must have a flexible approach to the … the demands of the department and of research trial participants. Please see attached job description for further detail. Person Specification Requirements Essential HCPC registration GCP Certificate Degree/Diploma in Diagnostic Imaging Significant experience as a Senior Radiographer Desirable CSI Experience MRI Research Paediatric experience Disclosure and Barring Service Check more »

patients. As a growing and successful business, we employ more than 1,300talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we … at Quotient comprises over 100 staff and provides an expert service in the data management, pharmacokinetics, programming, statistical analysis and reporting of early Phase clinical studies. Due to our continued growth and success we have an excellent career opportunity for a talented Programmer to join our Statistical Programming department … and creative in your programming skills. The Candidate The successful candidate will have a degree and SAS programming experience, ideally in an early phase GCP environment. Experience of programming clinical data, SDTM/ADaM datasets, listings, tables, figures and/or working with PK domains would be an advantage. more »

Job summary The post holder will be a key member of the clinical research team providing research support and its associated clinical care for participants and patients enrolling in a variety of research studies and projects. The post holder will be involved in providing ongoing support to the … research team. They will ensure data collection is to its highest standards, facilitating the production of good quality research with a commitment to the patients safety and wellbeing. You will be expected to participate fully in your personal and professional development and review progress in order to achieve the … training. Willingness to cover some out of hours work. Background acceptable for NHS honorary contract. Desirable Venepuncture skills Good Clinical Practice (GCP) training Experience Desirable Knowledge and experience of providing clinical care to patients with respiratory disorders Clinical research experience Disclosure and Barring Service Check more »

a super exciting pharmaceutical startup client based in Oxford. They are looking for someone to come and drive Good Clinical Practice (GCP) principles, who can come in and build relationships with key stakeholders in order to keep the quality team moving forward. The ideal person will have … strong QA experience within pharma and GCP, someone who is willing to be hands-on and into the detail expected when operating within a startup environment. This individual will also be a fantastic communicator, comfortable dealing with senior leadership and presenting up to that level. Responsibilities: Ensuring GCP is maintained … senior leadership and represent QA in reporting What you will bring: Previous project management experience within pharma/biotech or similar Outstanding knowledge of GCP, TFA and FDA regulations Strong project management principles, key knowledge of agile methodology A desire to be hands-on and into the thick of things more »

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 more than 20 therapeutic areas. With over … Experience may be substituted for education. 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 »

bioanalytical study or other plans Team player Review and sign of study data Responsible for regulatory compliance as assigned Ensure all processes are following GCP/GLP Liaising with clients regarding within agreed timescales Qualifications At least 3 years experience working in a regulatory bioanalytical laboratory. A degree in life … sciences or chemistry-related subject A good communicator with strong interpersonal skills. Experience working within a GLP/GCP accredited facility. Flexible and adaptable with an eye for detail Hand-on experience of LC-MS/MS, Sciex and Waters LC-MS/MS systems is an advantage Experience more »

delivering aspects of care in community settings which supports the Trust's vertical integration strategy. Main duties of the job Duties & Responsibilities The Direct Clinical Care PA's will consist attending on the ward, Neonatal Unit and Children's Assessment unit along with 1 in 10 night on call … to reflect the needs of the department, ensuring that contracted work is appropriately remunerated. An initial job plan review will be undertaken by the Clinical Director after 3 months and annually thereafter, or if the work pattern changes. Any additional PAs contracted by the Trust will be agreed as … higher degree Sub speciality interest in Neurology/cardiology , Acute Paediatrics or Neonatology Management/Audit Essential Participation in research and audit projects Desirable GCP training & Enthusiasm for clinical research Teaching Research/Publications Essential Enthusiasm to teach medical students, junior doctors and other staff on General paediatrics Desirable more »

work within the team. The post holder must ensure a high standard of project execution, adhering to research protocols and project proposals across various clinical specialties. This role is both challenging and diverse, working within a growing team that has multiple priorities. The candidate must possess excellent organisational skills … work within the team. The post holder must ensure a high standard of project execution, adhering to research protocols and project proposals across various clinical specialties. This role is both challenging and diverse, working within a growing team that has multiple priorities. The candidate must possess excellent organisational skills … with MS Office (particularly Excel) applications. Understanding and experience of research lifecycle. Understanding of research management systems. Awareness of Principles of Data Protection and Good Clinical Practice. Demonstrate a clear understanding of confidentiality. Experience of working in a busy environment working independently and exercising judgement and decision-making more »