26 to 50 of 59 Good Clinical Practice Jobs in the UK

Job summary The post holder will lead the provision of a high quality, safe and effective pharmacy clinical trials service, to ensure compliance with the required National Standards and UHBResearch and Development Strategy. The post holder will be the Pharmacy Lead Facilitator for Research and Audit projects. They will … own professional actions and deliver a high quality specialisedclinical pharmacy service to promote the safe, rational and cost-effective use of drugs,through personal practice and the training of other staff. The post holder will contribute to the training and education for Undergraduate HealthProfessionals and Post-Graduate Pharmacists, Nurses … Health Board's Research & Development department and, supported by our highly experienced Senior Pharmacy Trials Technician, will provide expert regulatory knowledge with regards to GCP and pharmaceutical aspects of clinical trial delivery and management. The ideal applicant will be a highly motivated and methodical pharmacist who is able to more »

Job summary We are looking for a dynamic and enthusiastic clinical pharmacist, looking to expand their knowledge and experience in clinical trials. If you have not worked in clinical trials before but would like to gain experience, then please apply. You will join a high-profile dedicated … healthcare professionals and other agencies relating to pharmaceutical aspects of clinical trials. To understand EU and UK Clinical Trial legislation relating to GCP, GMP and medicines management and ensure incorporation into the implementation of new clinical trials. To deliver specialist education and training in Clinical Trials … risk assessments. To work with and support the pharmacy team working within clinical trial implementation at UHCW. Assisting the team undergoing statutory MHRA GCP inspections and implement corrective or preventative actions. Assisting the development of policies, guidelines, audits and research relating to the use of medicines and devices within 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 »

Job summary An exciting opportunity has arisen for a well-motivated and enthusiastic Pharmacy Technician to join the Pharmacy Clinical Trials Team within Newcastle Hospitals Hospitals NHS Foundation Trust. You will have some level of managerial experience and be able to make on the spot decisions to enable the … responsible for the operational management and organisation of the pharmacy clinical trials service within the hospital site(s) involved. Ensuring compliance with ICH-GCP guidelines, clinical trials regulations, the research governance frameworks and other relevant guidelines and policies To develop, review and revise clinical trials documentation to … the service, we will do our best to make it work for you. Person Specification KNOWLEDGE Essential Up to date knowledge and understanding of GCP,GMP and its application Evidence of preparing worksheets/procedures Knowledge and understanding of the Law and Ethics relating to the dispensing of medicines. Working more »

Proclinical is seeking a dedicated individual for the role of Associate Director, Clinical Data Management. The successful candidate will be responsible for leading the team and overseeing the execution of clinical trials. Responsibilities: - Organise and conduct team meetings. - Foster team development and identify high-performance team members. - Collaborate … with the (Senior) Director Clinical Data Management on team development. - Provide guidance to project teams on the oversight and supervision of CRO/third party vendors and organize trainings as needed. - Act as a mentor for new team members. - Contribute to the development and review of portfolio documents (includes … Clinical Data Management with a focus on DM activities as a Lead and DM project management. - In-depth knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects. - Experience with Clinical Database Systems and processes. - Proven experience in resource planning. - A background in natural more »

is also actively involved in NHS, academic and commercial research. The post involves high volume, face to face contact with patients, including those in clinical trials/academic research studies, to acquire clinical data through a wide range of ocular imaging procedures and other ophthalmic assessments, determined either … through standard operating procedures/research protocols or ordered specifically for individual patients by clinical staff. Results are interpreted by clinical staff and inform patient management decisions. The post holder interacts routinely with: patients, administrative, clerical, technical and clinical staff within the Trust and other external stakeholders … the line manager. For a full list of duties, please refer to the attached job description and person specification Person Specification Qualifications Essential Current GCP Certification/NVQ 3 equivalent Up to date professional development plan Desirable Basic level media qualification AOSP Registration Previous technician certification for multicentre/international 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 »

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 »

responsibility for duties including: Designs and oversees the implementation quality management systems for CMC development activities including the release of product for GLP and GCP studies. Provides quality expertise in accordance with the global quality requirements in the creation of product characterisation, product specifications, method validation, stability and comparability assessments … in the collaboration with C(D)MOs. Ensures that there are robust processes in place for the review and release product for GLP and GCP studies. Ensures appropriate quality oversight of GMP activities performed by the Product Development teams at Dechra or CDMOs and contract laboratories. This may include review 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 »

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) * Experience of an Electronic Document Management System Skills: * Good inter-personal and communication skills * Good organisational and time management skills About Owlstone Medical Owlstone Medical is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy®. This involves collecting volatile organic compounds (VOCs) and … includes partnerships with major organizations including AstraZeneca, GlaxoSmithKline, the Cleveland Clinic, and the NHS and our platform is in use at well over 100 clinical and academic sites worldwide. Our leadership in breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical 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 »

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 »

in Europe & the only National Institute of Health Research (NIHR) Biomedical Research Centre (BRC) specialising in cancer. Our statisticians work under the Royal Marsden Clinical Trials Unit, and are exposed to the large, varied and innovative portfolio of studies ranging from early to late phase trials, and from simple … interventions. You will be involved in all aspects of study design, protocol development, database design, and statistical analysis. You will work in collaboration with clinical teams, and be given the opportunity to co-author conference abstracts and peer-reviewed journal papers, as well as attend internal and external courses … and Stata To gain/maintain knowledge of the EU directive on clinical trials (EU directive 2001/20/EC) and ICH GCP according to EU directive 2005/28/EC To gain a good knowledge of the clinical features, management and treatment of the more »

Proclinical is seeking a dedicated Manager of Global Trial Optimisation. This role involves overseeing the clinical development strategy, clinical study concepts and protocols as well as operational plans. The successful candidate will play a crucial part in maintaining relationships with external experts to facilitate a wide source of … to meet deadlines, effective use of time, and prioritization. - Ability to influence and negotiate across a wide range of collaborators. - Knowledge of ICH/GCP and regulatory guidelines/directives. - Advanced project management skills, cross-functional team leadership, and organizational skills. - A minimum of a Bachelor's degree and relevant … industry experience. - Direct experience managing global clinical trial operations, including experience developing protocols and key study documents. - Technical proficiency in trial management software and MS applications. Interested or know someone who might be? Reach out to ­­­­Matthew Pike using the following: ✉️ m.pike@proclinical.com 📞 +44 207 4400 639 (5342) Apply more »

research facilitators who will take responsibility for the smooth set-up of research across the trust. The role forms an essential bridge between investigators, clinical teams and funders, building accurate and comprehensive grant application costings and working through timely study set-up and delivery. This role will ensure the … largest acute teaching Trusts in England, we offer learning and development opportunities to help you achieve the career you aspire to. UHS is rated 'Good' by the CQC and in the latest national NHS Staff Survey, we were in the top 10 acute trusts for staff engagement and for … of the set-up or delivery of clinical research in a healthcare setting. Experience of delivery training Evidence of current and on-going GCP training Project management experience Knowledge of research governance and quality assurance systems to ensure safe systems for patients An understanding of current R&D issues 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 »

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 »

the sourcing, procurement and supply of unlicensed Medicines in line with National Guidance To help network with other Trust pharmacy departments to share best practice To contribute pro-actively to regular weekly team meetings to encourage staff ideas, service improvements and patient safety. Analytical Skills Help ensure statistical information … Head of Pharmacy/Chief Pharmacist as appropriate, when required. To assist with reporting on any current and future (horizon scanning) changes in prescribing practice and report on how this change in practice may affect the drug budget. Help ensure the recording of any drug defects (and sending … followed with patient identifiable data Responsibility for research and development To be authorised to receive and confirm receipt of clinical trial medication following GCP guidance and ensure that relevant records/information is documented and stored . Person Specification education and training Essential oRegistered Pharmacy Technician with GphC Experience more »

Within pharmacy we have a position for a senior assistant technical officer. We are looking for an enthusiastic person to join our small pharmacy clinical trials team. We are responsible for ensuring that all the pharmacy and medicine aspects of clinical trials for cancers are conducted according to … daily basis providing feedback to relevant individuals as necessary. Management of IMP stock levels to include ordering, receiving, relabelling, archiving, according to Sponsor and GCP requirements To undertake routine expiry date checks and maintain the expiry date database. Arrange and act as a pharmacy representative at trial monitoring and close … field telephone calls and enquiries as appropriate. Person Specification Qualifications Essential NVQ 3/equivalent GCSE or equivalent passes in Maths, English and Science GCP training within last 2 years Desirable Excel and use of Microsoft office programmes Experience Essential Experience of using a variety of IT packages to include more »

of Quality Assurance is to promote a quality culture of continuous improvement to ensure all systems and procedures undertaken are in compliance with ICH-GCP guidelines and other regulatory requirements. Main Responsibilities Ensure Non-Conformances/Incident Reports are reviewed, assessed and approved using the eQMS ensuring it is contributing … to continual quality improvement. Ensure Quality Documents are reviewed for process improvements, are of a high standard in accordance with ICH-GCP, and approved using the eQMS. Ensure external Sponsor audits or Inspections are prepared, hosted including timely provision of document requests, and for any findings CAPAs are raised, reviewed … necessary. Organising QA training for all staff - including distributing workload and monitoring task completion. Qualifications and Experience: At least 6 years of experience in GCP Quality Assurance within the Pharmaceutical Industry. Strong knowledge of Quality Management Systems within the Pharmaceutical industry. Strong knowledge of ICH-GCP and GMP guidelines. Experience more »

via literature searches. Providing an indication of any potential difficulties with bioanalytical methods and assisting with client calls and visits. Working to GLP/GCP and showing good documentation practice. The Person A successful candidate will have previous experience working in a regulatory bioanalysis lab with experience performing LC … experience of using LC-MS/MS. Previous experience of troubleshooting Have previous experience performing sample extraction techniques for biological analysis. Must be a good communicator with excellent interpersonal skills. Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this 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 »

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 »

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 »