26 to 50 of 67 Good Clinical Practice Jobs in the UK

Proclinical is seeking a dedicated and proactive Director of Clinical Compliance. This role focuses on establishing and implementing a Quality Strategy for clinical development activities. The successful candidate will ensure all work is in agreement with regulatory requirements and will adherence to Good Clinical Practices. This … alternatively can be a hybrid working role based in Mainz, Germany. Responsibilities: Provide strong QA leadership, fostering organizational awareness and interdepartmental collaboration. Implement the Clinical Development Quality Plan within the development portfolio. Provide robust quality oversight in various areas, including risk detection and remediation. Offer guidance on day-to … CAPA preparation. Lead a team to ensure a unified approach to proactive support for clinical trials. Key Skills and Requirements: Experience in a GCP Environment within the Pharmaceutical or CRO Industry. In-depth knowledge of worldwide regulations (including FDA, EMA) related to clinical development and post-approval. Experience 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 »

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 »

lives. Responsibilities: Drive risk-based approach to solve complex business problems. Provide expert input to functional teams in areas such as Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs and Companion Diagnostics. Drive change … Skills and Requirements: Significant understanding within GxP operational and quality roles. Operational experience in at least one of the following areas: Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs or Companion Diagnostics. Strong and … development and development of medical devices is a plus. Strong knowledge of Clinical Development and Research operations and regulatory landscape. Deep knowledge of GCP, GLP, GPVP, GCP for Labs and a general understanding of GMP. Expert in process development, industry standard problem-solving approaches, in alignment with Lean and 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 »

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 »

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 »

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 »

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 »

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 »

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 »

Trial Master File Expert Our client is a young innovative clinical stage Biotech company with a strong development pipeline, now have approval for a new position for a Trial Master File (TMF) Expert within the Clinical Development and Operations group. There is flexibility for this hire to work … Director of Clinical Development and Operations, this hire will manage TMFs, Sponsor Oversight File (SOF) and Archiving for all studies according to ICH-GCP and other regulatory requirements. This TMF Expert will work closely with Clinical Project Managers across Phase I-III trials, covering multiple responsibilities of outsourced … Science degree is preferred. 10+ years’ experience managing TMFs in Clinical Operations environment, in the pharmaceutical, biotech or CRO industry working ICH/GCP guidelines. Experience in both paper and electronic TMF, and familiarity with naming and filing conventions and the CDISC TMF Reference Model and applicable industry guidelines 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 »

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 »

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 »

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 »