1 to 25 of 53 Permanent Good Clinical Practice Jobs in the UK

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 »

Director, QA (GCP) Full-time, Permanent London- Hybrid Model Summary: I am currently working with a pioneering biotech reshaping healthcare through genetic engineering and personalized medicine. In this crucial position, as the Director QA GCP, your responsibility will be to assist upper management in guaranteeing that Quality remains a central … focus in all corporate endeavors. More specifically, you will serve as a consultant to the Clinical Development teams, providing guidance on GCP activities related to quality. Primary Responsibilities: Defining, maintaining, and monitoring the GxP Quality Management System (QMS). Making sure the QMS meets all the necessary regulatory requirements … with a strong focus on GCP compliance. Supporting and guiding the Clinical Development teams in defining compliant procedures within GxP functions and effectively managing quality issues. Handpicking and documenting responsibilities for external contracted organizations that support the GxP activities. Keeping a close eye on the performance of the GxP 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 »

projects ensuring efficient project management, compliance, and high-quality deliverables. You will have the chance to contribute to improving healthcare through medicine by analysing clinical trial data, providing statistical consultancy, and mentoring junior colleagues. Please note that to be considered for this role you must have the right to … Responsibilities Apply innovative statistical approaches to solve novel data challenges. Lead projects, ensuring efficient project management, compliance, and high-quality deliverables. Analyse phase III clinical trial data to support HTA submissions. Provide statistical consultancy to internal and external customers. Plan, analyse, and visualise observational and real-world data. Support … equivalent knowledge/expertise. 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 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 »

Job Title: Head of/Director Quality Assurance (GCP) Location: Central London (4 days on site) Type: Full-time, Permanent A renowned organisation specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors seeks a dedicated Head of/Director Quality Assurance. Embracing a culture of excellence and … the development of transformative therapies. Responsibilities: Oversee quality assurance initiatives throughout the organisation, fostering a culture of continuous improvement to ensure compliance with ICH-GCP Guidelines and other regulatory standards. Identify and communicate observations or deviations encountered in day-to-day operations, actively participating in their resolution to maintain quality … Incident Reports (IRs) through the electronic Quality Management System (eQMS), driving continual quality enhancement. Review and approve Quality Documents to ensure adherence to ICH-GCP standards and process improvements, leveraging the eQMS. Prepare for and host external Sponsor audits or Inspections, facilitating timely provision of documentation and addressing findings through 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 »

India, Denmark, UK, Singapore etc. (www.tech-observer.com) We are hiring for following roles on FSP: a. Statistical programmers : 5-8 years of exp in clinical SAS Programming Senior Statistical Programmers : 8-12 years of exp in clinical SAS Programming b. Principal Statistical programmers : 12+ years of exp in … clinical SAS Programming Location -United Kingdom (candidates eligible to work in UK shall be considered) Work Timings : US Timings (EST -3 days and PST … days) Job Responsibilities- 1.Compliance with working SOPs within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensure adherence to programming guidelines. 2. Implement and follow the latest versions of CDISC, FDA Guidelines, GCP and other industry standards. 3. Participate in and 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 »

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 »

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 »

Job summary An exciting opportunity has arisen for a Specialist Clinical Trials & Cancer Services Pharmacist to join the Cancer and Aseptic Services team at ESHT. The successful candidate will lead on a portfolio of cancer & non-cancer clinical trials undertaken … within ESHT. They will appraise all relevant clinical trials & offer pharmaceutical input in accordance with legal requirements & Good Clinical Practice (GCP) relating to the prescribing, handling, dispensing, administration, storage & disposal of investigational medicinal products (IMPs) & non-investigational medicinal products (NIMPs). They will also contribute to … the delivery of a high quality specialist clinical pharmacy service to cancer clinical services. Experience in Cancer &/or Aseptic Services is essential. They will not only have the opportunity to explore & enhance their clinical expertise, but will also be developing management, training & leadership skills. They will more »

us You will join a small pharmacy-based team, where you will help to ensure the standards of Good Clinical Practice (GCP) are followed and that patients who volunteer to take part in clinical trials feel valued and receive an excellent pharmacy service. You will work … Operating Procedures (SOPs). To prepare invoice requisitions for clinical trial fees and monitor the receipt of income for specific trials. To attend GCP training as required by the Trust and to work to GCP standards at all times. To attend meetings regarding the set up and running of … Level 3 Pharmacy Services, BTEC Pharmaceutical Sciences or equivalent Registered Pharmacy Technician with the General Pharmaceutical Council Accredited Checking Pharmacy Technician (ACPT) qualification Desirable GCP training Skills and Experience Essential Good understanding of Clinical Trials Experience of working in a hospital pharmacy Evidence of working in a team more »

Manchester Childrens Hospital. As the Paediatric BMT Data Manager you will be responsible/for the high quality capture, processing and submission of complex clinical data from clinical systems within the Trust, ensuring the data is handled in a timely manner in line with EBMT recommendations. This includes … Operating Procedures (SOPs) with respect to the Data Protection Act, the Freedom of Information Act and ICH Good Clinical Practice (ICH GCP). To work alongside other Data Managers and Data administrators with the data entry and configuration tasks necessary to support the BMT Electronic Database (Access … Operating Procedures (SOPs) with respect to the Data Protection Act, the Freedom of Information Act and ICH Good Clinical Practice (ICH GCP). To work alongside other Data Managers and Data administrators with the data entry and configuration tasks necessary to support the BMT Electronic Database (Access 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 »

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 »

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 DescriptionWorking as a Senior Quality Expert/Manager - GCP, you will act as the advisor to the Clinical Development teams on all quality related GCP activities. This will be an exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets.Key Responsibilities:To play a … key role in maintaining and monitoring the GxP QMS ensuring it meets all regulatory requirements and standards, with emphasis on GCP compliance.To provide support and advice to Clinical Development teams with regards to:Definition of appropriate compliant procedures within GxP functionsManagement of quality issuesTo ensure external contracted organisations supporting … monitor the performance of GxP service providers with regards to the relevant quality standards.To define and manage clinical audit programme and to preform GCP audits if required.Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified.To maintain more »

CK Group are recruiting for a Scientist II – Clinical Chemistry to join a leading laboratory specialising in clinical trials, central lab services and toxicology. Candidates for this role must have a minimum of 12 months experience in Clinical Chemistry from a diagnostic or clinical trials laboratory … setting. Location: York, full time onsite. Hours: Tuesday to Saturday, daytime hours. Your main duties will be to: Perform analysis on clinical trials samples to the required standards within the determined timeframes. Review, authorise and report results using the Laboratory Information Systems. Document quality events within the Quality Management … Sciences or equivalent Background in practical and/or theoretical blood sciences is desirable. Appreciation for working in a regulatory environment (experience working to GCP is desirable) Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 101465 in all correspondence. more »

Job DescriptionHead of Clinical Data - Cambridge/London - Exciting MedTech Start … Up 🚀📢 Permanent + Tech-for-Good + Share options schemeDo 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 … start-up which aims to combine technology and medicine to improve the lives of patients who are dealing with complex diseases by using clinical data and Machine Learning technology. You’d be responsible for the data contracts that the company has with their partners as they run clinical more »

Hobson Prior is seeking a Biomarker Scientist to support clinical transcriptomics outsourced activities. The successful candidate will be responsible for conducting and supporting sample analysis, quality control, data interpretation, and reporting. This role requires staying updated with new and emerging techniques in the transcriptomics and biomarker fields. Please note … considered for this role you must have the right to work in this location. Key Responsibilities Act as a Subject Matter Expert in supporting clinical transcriptomics outsourced activities from planning and technical perspectives. Ensure timely delivery of high-quality, fit-for-purpose assays and robust data. Conduct and support … Experience of working with human tissue under the directives of the Human Tissue Act (HTA), and experience of working with samples and studies under GCP compliance. Practical experience in any of the following techniques would be an advantage: histology and immunohistochemistry, Immunoassay and ligand binding assays, Flow cytometry assays, LC 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 »