1 to 25 of 63 Good Clinical Practice Jobs in the UK

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 »

The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to: * Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures … good clinical practices and other applicable regulatory requirements; * Validating product performance claims; * Supplying data for critical Regulatory submissions; * Defining the functional and clinical utility of investigational products, and * Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The … adhering to the policies of the quality system and achieving quality objectives through daily actions. JOB FUNCTIONS/RESPONSIBILITIES * Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Maintaining communication with study investigators to ensure studies are completed in a timely more »

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 »

Proclinical is seeking a dedicated and experienced Senior GCP Quality Auditor. This role is an integral part of the growing global team, contributing to the development and enhancement of audit strategy. The successful candidate will be responsible for conducting and managing audit activities in line with regulatory requirements and company … processes/procedures. Skills and Requirements: Bachelor's degree in a scientific or health-related field. Lead auditor qualification/certification. Experience in conducting GCP audits. Knowledge of regulatory inspections related to GCP is advantageous. Ability to work independently without supervision. Interested or know someone who might be? Reach out more »

is currently collaborating with a CRO, who are actively seeking a Head of Quality Assurance to oversee and uphold the highest standards within our clinical research processes. In this pivotal role, you will lead a dedicated team committed to maintaining excellence and … driving continuous improvement. Your responsibilities will include ensuring that our operations align with the rigorous standards outlined in Good Clinical Practice (GCP) guidelines and regulations. Please note that to be considered for this role you must have the right to work in this location. Key Responsibilities Create … within the pharmaceutical industry. Deep understanding of Good Clinical Practice guidelines, regulations, and standards. Relevant certifications such as RQAP-GLP, RQAP-GCP are desirable. Leadership experience along with excellent communication, collaboration, and interpersonal skills. Detail-oriented with strong analytical and problem-solving abilities. Proven ability to drive more »

Background must be in pharma NOT medical devices) Senior R&D QA GCP Auditor (pharmaceuticals) I'm looking to recruit a seasoned Senior R&D QA GCP Auditor responsible for ensuring compliance and proper implementation of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice … the clinical development of Global R&D projects in the UK and EU settings. The ideal candidate should possess substantial experience as a GCP-GCLP auditor in pharmaceutical firms or Contract Research Organisations (CROs), as well as relevant experience in managing clinical trials involving investigational medicinal products as … managing audit results (non-conformities). the Unit Head's responsibilities in gathering data to aid in the annual audit program's preparation for GCP and GCLP auditing activities. in keeping the yearly audit programme for GCP and GCLP auditing operations updated and monitored. pertaining to GCP-GCLP auditing operations 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 »

to advancing health through innovative solutions and maintaining the integrity of our processes and products. We are currently seeking an experienced and detail-oriented GCP Auditor to join our team. Job Summary: As a GCP Auditor at you will be responsible for planning, conducting, and reporting on audits to ensure … compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and company policies. Your role will involve auditing clinical trials, vendors, and internal processes to ensure that our clinical research activities are conducted with the highest level of quality and integrity. Key Responsibilities: Plan, schedule, and … conduct GCP audits of clinical trials, sites, vendors, and internal processes. Develop audit plans, checklists, and reports. Identify and document audit findings, non-compliance issues, and areas for improvement. Provide clear, concise, and actionable audit reports to relevant stakeholders. Follow up on audit findings to ensure timely and effective 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 »

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 »

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 »

Team. Experience as a BA - circa 5+ years to work independently. Experience with Veeva and other quality systems. Must understand GXP. Order of focus - GCP, GDP/GMP and then GLP. Extensive experience and knowledge in Quality Assurance in Pharma/biotech space to interact with stakeholders. Not a validation 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 »

Senior Project Clinical Data Manager We have the pleasure of working with a fantastic early phase CRO based in London. The company have a strong leadership team who are accelerating growth and have a great vision for the future. The offices are very modern and they have a fully … primary Data Management Lead for assigned projects ensuring clinical projects are carried out by the company in accordance with the executed contract, ICH GCP and other relevant regulations and guidelines and the customer’s expectations, taking responsibility for resourcing and planning of assigned projects. Provide hands on technical data … RFP) and Request for Information (RFI) process. Prepare input and participate in bid defence meetings Essential Degree or equivalent Knowledge of current regulatory regulations, GCP, ICH guidelines and Data-management industry standards SAS programming Detailed experience of end to end Clinical trial and Project Data Management processes, as well more »

Our client, a leader in clinical operations, is seeking a Program Manager to address compliance gaps in line with the new European Medicines Agency (EMA) guidelines for computerized systems and electronic data in clinical trials. This is an exciting opportunity to lead key initiatives that are critical to … clinical, quality, regulatory, and IT departments, to ensure cohesive and comprehensive project execution. Maintain up-to-date knowledge of GXP regulations, including GMP, GCP, and GLP, to ensure all project activities comply with these standards. Oversee and ensure quality control throughout the project lifecycle. Identify potential risks and develop … a Program Manager in clinical trials, with a strong focus on quality and regulatory compliance. In-depth understanding of GXP regulations, including GMP, GCP, and GLP. Demonstrated experience in managing projects related to EMA guidelines for computerized systems and electronic data. Exceptional project management skills, including planning, execution, monitoring 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 »

Neurosurgery (NHNN), Queen Square. The holder of this post will rotate through various firms. The post holder will have the same educational opportunities and clinical and educational supervision arrangements as the other neurology/stroke SpRs with NTNs. This position is for 6 months starting in August 2024. Main … duties of the job The Trust Grade Doctor will have primary charge of the day to day care of Neurology/Stroke inpatients. Clinical duties will include attending consultant ward rounds, attending outpatient clinics and mdt meetings. The post holder will provide neurological assessment and clerking at admission and … 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. Job description more »