1 to 25 of 58 Good Clinical Practice Jobs in the UK

R&D team to cover a 12 months maternity leave vacancy. You will work alongside a colleague to manage patient data relating to the clinical research outcomes of patients cared for with Metabolic disorders. You will be involved in all aspects of clinical trials, including research study set … roles and when that happens we sometimes bring the closing date forward, so please apply promptly to avoid disappointment. Person Specification Qualifications Essential NIHR Good Clinical Practice Trained A Degree or Equivalent experience within Research Knowledge & Nature of Experience Essential Previous experience in setting up and coordinating … in the NHS Practical knowledge of the governance and legislative framework for conducting clinical research studies, including Good Clinical Practice (GCP) Desirable Previous experience in Research Grant/Commercial study costing processes Knowledge of the Data Protection Act in relation to research and clinical care more »

Career Category Clinical Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s … delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. CLINICAL DATA MANAGEMENT MANAGER LIVE What you will do In this vital role you will responsible for ensuring clinical projects are executed according to … study level non-DM documents for awareness and project level consistency. Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study/vendor level. Lead or participate in the development, review and implementation of processes more »

ensure correct data collection 3. To be responsible for forwarding trial data in a timely manner to the trial co-ordinating centre. Liaise with clinical trial personnel outside the hospital as necessary. 4. To assist in the review of trial protocols and identify resource implications for the site. 5. … To check eligibility of patients into trials and to ensure that all relevant data has been recorded 6. To take responsibility for liaising with Clinical Trials Units regarding data queries and for checking and resolving data queries 7. To contribute to the development of clinical and research policies … assist with where appropriate the establishment and maintenance of trial site files for trials in accordance with ICH good clinical practice (GCP) and Research Governance 10. To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the protocol more »

coordination all clinical trial functions within aseptic services to meet the needs of the service. Ensure compliance to procedures and national standards (GMP, GCP and The Medicines for Human Use (Clinical Trials) Regulations 2004). About us Cardiff and Vale University Health Board is one of the largest … communication and interaction skills. NVQ L3/BTEC Pharmacy services Good working knowledge of safe dispensing and aseptic practices Knowledge and understanding of GCP/GMP legislation and QA and its application to aseptic processing Able to demonstrate excellent organisational skills Good attention to detail and responsible attitude … quality and accuracy Experience in Clinical Trials day to day running of service, attending meetings, co-ordinating aspects related to organisation of trials GCP/GMP legislation (including preparation for inspection), clinical trial set-up and management, manufacture of IMPs and QP release, clinical trials in specialist 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 »

Associate Director Clinical Biomarkers, Oncology EMU Are you interested in developing, integrating, and implementing innovative biomarker strategies for Oncology clinical development programs, including validation and integration of biomarker assays into clinical trials? If so, the Clinical Biomarker Lead role within Experimental Medicine Unit (EMU) could be … wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will Lead and/or contribute to clinical asset biomarker strategy within early and late-stage clinical development programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action … time. Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms Knowledge and track-record of working to GCP principles. Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment Strong more »

an extremely cutting edge area of the life sciences space. chance to sit alongside the businesses senior leadership team, having full autonomy of the clinical division within the QA department. a small team of quality professionals, supporting with development and training. You will be responsible for: the businesses quality … high standard and aligns with regulations. CQA oversight and support to Pre-Clinical and Clinical Operations. and host regulatory inspections within the GCP remit. You will bring the following: extensive number of years working at a senior manage level within GCP/GLP function. track record of establishing more »

all of the information before applying for the vacancy. Main duties of the job The post-holder will take responsibility for a portfolio of clinical trials as part of our Oncology & Haematology Trials team. This often challenging post will see you working to tight deadlines to transfer data from … participant's clinical records into case report forms. Responsibilities will include liaising with Sponsors, Trust and University staff, preparation of support documentation for the clinical team and maintaining accurate records. You will work closely with the rest of our Multi-Disciplinary Team to provide the best service possible … policy regarding Data Protection - Caldicott Guidelines, Data Protection Act Desirable Good working knowledge of clinical trials and the regulatory bodies to include: GCP, ICH Knowledge of eRecord EXPERIENCE Essential Previous database experience Must be experienced in all aspects of Microsoft Windows applications Previous experience of data management Desirable more »

Job summary Band 3 Clerical Officer (Clinical Trial Assistant) - Clinical Trials Unit, Bristol Haematology & Oncology centre Full time 37.5 hours. Permanent position. We are looking for an enthusiastic and motivated person to join our team within the Clinical Trials Unit at the Bristol Haematology & Oncology Centre. You … range of clerical and administrative duties as part of this post. Previous clerical and administrative experience is essential, along with excellent organisational skills and good literacy and numeracy. You will be I.T. proficient in a number of packages such as MS Word, Excel and Outlook and willing to learn … including cancellation of clinics and alteration of appointment slots as and when required and under supervision of the Administration Team Requesting CV's and GCP certificates, as well as PI oversight where applicable, from Research Personnel on an on-going basis and keeping an up to date record of documents more »

duties of the job Working autonomously, under the direction of the relevant research team leader, the post holder will collate data produced by the clinical teams and enter appropriately into paper or electronic case report forms (CRFs). In addition, the … post holder will liaise with trial sponsors to ensure timely transfer of data, and resolving any data queries, working within the guidelines of ICH GCP and local SOPs at all times. Other responsibilities will include assisting with the creation and maintenance of Investigator site files and databases of clinical … Values Education & professional Qualifications Essential oScience related degree or equivalent oKnowledge of drug development process and concept of clinical trials oKnowledge of ICH GCP Experience Essential oExperience of working under minimal supervision oExperience of working as part of a team oExperience of working to deadlines oComputer literacy to include more »

role: Applying innovative statistical approaches to solve novel data challenges Leading projects, ensuring efficient project management, compliance, and high-quality deliverables Analysing phase III clinical trial data in order to support HTA submissions Providing statistical consultancy to internal and external customers Planning, analysing, and visualising observational and real-world … with proven industrial experience Knowledge of HTA-related statistical methods, including ITC, NMA, and complex statistical modelling techniques Awareness of regulatory standards, ICH/GCP guidelines, and HTA regulations Understanding of the clinical drug development process Proficiency in statistical programming languages (SAS and/or R) Strong problem-solving more »

you to have: BSc/MSc/PhD in Chemistry (or related scientific discipline) A sound working knowledge of relevant quality standards; GMP, GLP, GCP and other analytical related quality standards Good working knowledge of Quality Assurance in the Chemical and Pharmaceutical Industry Quality Assurance background which includes some … attention to detail Impressive written and verbal communication ABOUT THE OPPORTUNITY You will provide general support to Quality Assurance activities relating to GLP, GMP, GCP, and other similar Quality Systems established to ensure that the appropriate standards and effective working systems and relationships are maintained and where necessary improved. Responsible … for auditing GLP, GCP and GMP plans, raw data, study procedures and related facilities to ensure compliance with current relevant regulatory requirements and internal consistency, Identify and report any areas of non-compliance to both study and facility management. Liaise with key stakeholders, providing them with accurate information and progress more »

Associate Director Quality Assurance SUMMARY: The Associate Director, Quality Assurance is tasked with implementing strategies to ensure successful delivery of high-quality Clinical Trials studies. This involves driving effective and efficient global processes within the realm of Quality and Operations. This leader collaborates closely with the Clinical Trials … Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) strongly preferred. RESPONSIBILITIES: Leadership. Strategic partnership with Global Quality Assurance team and Global Leadership Team Regional oversight of Quality Assurance teams Daily management activities for … Maintenance of a working knowledge of industry and regulatory standards and requirements Provision of guidance and leadership on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, data privacy, and other relevant regulatory standards Responsive escalation point for Clinical Trials quality issues and 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 »

plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and continuously improving the site's … Qualifications Bachelor’s degree (preferred) 3+ years of experience in a laboratory, pharmaceutical, medical device, or clinical research organization (required) Demonstrated experience in GCP, ISO15189, NEQAS, CAP, CLIA (strongly preferred) Certified Quality Auditor (preferred) RESPONSIBILITIES Quality Assurance Responsibilities: Ensure the efficiency of the Quality System/personnel for the … Act as Deputy Archivist, responsible for maintaining the archive and its contents in compliance with relevant regulations. Introduce systems to comply with revised GLP, GCP, EMA, FDA, and OECD guidelines or regulations. Provide support/host customer-initiated audits, mock regulatory inspections, and regulatory facility inspections. Participate in the review more »

well established QA function. KEY RESPONSIBILITIES: Coordinating the implementation of the company's quality management system pertaining to Good Clinical Practice (GCP), including oversight of external vendors, training on quality procedures, and performance monitoring against established standards. Serving as the main point of contact and providing support … Supporting the planning and execution of audits, including those conducted internally, at vendor sites, clinical sites, external laboratories, and suppliers. Providing guidance on GCP/GCLP/GLP practices to clinical project teams and identifying/mitigating operational risks and deviations. Overseeing Change Controls, Deviations, and Corrective and … any findings. Delivering training to laboratory teams as needed. Experience Needed: Minimum 4+ years of experience in the pharmaceutical/biotechnology industry in a GCP QA role, with experience in providing quality support to clinical laboratories. Experience in providing quality support for Cell or Gene Therapy programs is highly 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 »

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 »

the Quality System by supporting global metrics generation and ‘lessons learned from audit/inspection’ · Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV. · Collaborate with the respective Functional Area Heads/representatives · Collaborate with the respective Global and Regional Quality Leads and functions · Ensure …/EXPERIENCE · Degree in natural science or equivalent number of years’ experience · Experience in Pharmacovigilance auditing (Qualification as an auditor preferred) · Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation · Expert … knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance · Experience in Monitoring, Quality Assurance and/or Good Clinical Practices · Exposure to inspections COMPETENCIES · Understanding of pharmacovigilance · Understanding of audits and more »

their laboratories engaged in exploratory analysis of patient samples. You will be responsible for: Implementation of the company's quality management system relevant to GCP, including laboratory analysis of clinical samples, external vendor oversight, and training on quality procedures Acting liaison and support for Immunomonitoring and R&D labs … training to laboratory teams and eQMS users Plan and conduct of audits, including internal, vendors, clinical sites, and external laboratories Provide guidance on GCP/GCLP/GLP to clinical project teams You will bring the following: Previous experience in GCP QA role, as well as working in … Clinical laboratories Experience in Biologics, Steriles, CGT, or ATMP is highly desirable In depth knowledge of GCP and GCLP practices and regulations eQMS experience including implementation and administration more »

across PM. Support the development and validation of biomarker assays and Precision Medicine Solutions. Facilitate/participate in projects to deliver improvements to the clinical laboratory Quality Management System through collaboration with R&D Understand the business needs of PM departments, with respect to technology infrastructure, third party work … Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree Extensive R&D experience including experience in clinical development. Understanding of drug development and approval process and life cycle management Broad knowledge of technical platforms that include IHC, immunoassay, PCR, NGS … and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies) Experience in performing due diligence and auditing vendors for CDx test placement. Understanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations more »

Job Title: Project Coordinator Department: Project Management Company: WEP Clinical Location: Hybrid - Chiswick Tower, London, England Do you dream of being part of a team that brings hope to those who need it most? Are you searching for a career that challenges you and allows you to grow as … a professional? At WEP Clinical, we are expanding, and the opportunities for personal and professional development are endless. Our team is committed to providing patients with early access to life-changing medicine every day. We encourage our team to bring their most creative and innovative ideas. Join us today … ensure projects are completed in accordance with client expectations. Assist with project documentation collection and review from investigational sites, ensuring they meet FDA/GCP/ICH requirements. Support preparation of study files based on project scope including maintenance of internal or external document storage systems including Electronic Trial Master more »

Head of Clinical Data - Cambridge/London - Exciting MedTech Start-Up … Permanent + Tech-for-Good + Share options scheme Do you have a strong interest in the HealthTech and MedTech industry? Are you GCP trained with a Medical Degree and experience working in NHS? We’re looking for a Head of Clinical Data to join this exciting MedTech … universities Experience working in the NHS Experience working with data policies and GDPR Experience working with medical data contracts such as EHR and PACs GCP trained Great problem-solving abilities Excellent time management and communication skills What’s in it for you 💰: Competitive starting salary Share options scheme Hybrid working 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 »

The focus of this role is leading a team of scientists to deliver development, validation and sample analysis projects within Immunoassay. You will build close relationships with a number of our customers and be responsible for delivering high quality results more »