1 to 25 of 47 Good Clinical Practice Jobs in England

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 »

/life balance. What we are looking for Life science degree. Extensive auditing experience in GCP. Thorough knowledge of GCP. Able to confidently audit GCP Vendors or Investigator Sites with limited oversight. Strong client focus. What You’ll Do With Us Focusing on delivering top-class audits to our list 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 the UK. The successful candidate will work within our multi-disciplinary Delivery teams supporting the implementation of our next generation patient-centric remote clinical trial solutions. WHAT WILL YOU DO? You will be an integral part of our testing team responsible for testing our mobile applications and web … e.g., Python, Java, JS,) and experience in YAML An understanding of data validation and verification processes. Exposure to Good Clinical Practice (GCP) guidelines. Competence in analysing clinical data for consistency and accuracy. Candidates with past experience within in the clinical trial industry will have a … by building data capture solutions people love to use. Designed with patients for patients, the uMotif platform supports data capture for each phase of clinical research across all therapeutic areas. Over 22,000 participants use our applications to track and submit e-consent, symptom, eCOA, ePRO, and wearable device 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 »

work in a multidisciplinary environment Effective verbal and written communication skills Understanding of principles of audit and clinical governance Desirable Previous audit completed GCP certificate of Good Clinical Practice Communication Essential Demonstrable skills in written and spoken English that are adequate to enable effective communication about more »

regulations, and guidelines within the NHS or relevant healthcare setting. Familiarity with relevant legislation, such as the Human Tissue Act, Data Protection Act, and Good Clinical Practice guidelines. Excellent communication skills, including being able to communication highly sensitive and complex issues to managers and staff. Ability to … are achieved. Desirable Possess highly developed, specialist knowledge related to research activity/research governance. Continuously updates specialist knowledge relating to research governance, ICH GCP guidance and UK directives. Knowledgeable of current, potential research and information relevant to the care of patients within specialist clinical areas and relevant to … clinical trial participation. Excellent IT skills, ITQ/ECDL or knowledge through broad experience. In depth knowledge of NHS organisations and the challenges they face. Experience Essential Extensive background in roles closely tied to research, innovation, or a pertinent scientific field, showcasing substantial expertise. Proven proficiency in research processes 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 »

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 »

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 »

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 »

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 »

the life sciences industry (CRO, pharmaceuticals, biotechnology, etc). The ideal candidate will possess a deep understanding of Good Clinical Practice (GCP) and its application in research studies. In addition, they will have proficiency in industry-standard clinical database applications, such as Electronic Data Capture (EDC … and Clinical Trial Management Systems (CTMS). Experience with programming languages like JavaScript or SQL is a strong plus. Company: CYTE is a full-service cardiovascular contract research organisation (CRO) powered by an integrated Clinical Research Platform and a Global Site Network. We provide research solutions to our … services. Role & candidate profile: Clinical Data Manager will ensure CYTE studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, CYTE SOPs and all applicable regulatory guidelines. Responsibilities: CRF design, database specification and edit check specification creation based on study protocols. EDC build and more »

Job summary Applications from a variety of different clinical/professional backgrounds are invited, including Nursing, AHPs, Psychology, etc. All applicants must be able to demonstrate that they meet the essential criteria. We have a fabulous opportunity to join Derbyshire Healthcare's Research and Development team based at the … invited for a fixed term contract opportunity to end of FY 24/25, with potential for extension beyond, for a Band 6 Lead Clinical Researcher/Research Nurse/Research OT (depending on the applicant's professional/clinical background) role, based within the Centre for Research … and Development at Derbyshire Healthcare NHS Foundation Trust.If you want to gain research experience by using your clinical skills to support the delivery of high quality nationally funded research focused on improving patient care in the NHS, please apply. "It is Trust policy that for posts that are for more »

Associate Director of GCP | Permanent | Hybrid - Oxford | Circa £95k We are currently working on a new Associate Director of Good Clinical Practice position at a super exciting pharmaceutical startup client based in Oxford. They are looking for someone to come and and be the right-hand person … deputising for them, sharing responsibility and leading the team when required. The ideal person will have strong QA and managerial experience within pharma and GCP, someone who is willing to be hands-on and into the detail expected when operating within a startup environment. Responsibilities: Ensuring GCP is maintained and … to senior leadership and represent QA in reporting What you will bring: Roughly 7+ years working in a leadership QA position Outstanding knowledge of GCP, TFA and FDA regulations Strong management skills A desire to be hands-on and into the thick of things Logistics: Salary of around 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 »

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 »

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 »

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 »

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 »

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 »

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 »

involved in NHS, academic and commercial research. The post involves high volume, face to face contact with patients, principally in the glaucoma service acquiring clinical diagnostic data to support and inform clinicians. The post holder interacts routinely with: patients, administrative, clerical, technical and clinical staff within the Trust … date professional development plan Desirable AOSP/ACHS Registration Previous technician certification for multicentre/international clinical trials Member Ophthalmic Imaging Association Current GCP Certification/NVQ 3equivalent Experience Essential Experience in ophthalmic imaging/retinal screening Evidence of recent professional development. Desirable Experience in a commercial photographic environment. more »

s Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high-quality care, clinical excellence, research and innovation. We are among the UK's busiest, most successful foundation trusts. We provide specialist care for patients including heart and … as well as a full range of local hospital and community services for people in Lambeth and Southwark. We have a long tradition of clinical and scientific achievement and - as part of King's Health Partners - we are one of England's eight academic health sciences centres, bringing together … world-class clinical services, teaching and research. We strive to recruit and retain the best staff as the dedication and skills of our employees lie at the heart of our organisation and ensure that our services are of the highest quality, safe and focused on our patients. Job description more »