1 to 25 of 55 Good Clinical Practice Jobs in England

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 »

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 »

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 »

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 »

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 »

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 »

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 »

clinical trials of medicinal products and all aspects of pharmaceutical input in accordance with legal requirements and Good Clinical Practice (GCP) relating to the prescribing, handling, dispensing, administration, storage and disposal of investigational medicinal products (IMPs) advanced therapy investigational products (ATIMPs) and non - investigational medicinal products … Takes responsibility for the provision, management and development of a high quality, comprehensive specialist clinical trials pharmacy service 5.1. Works according to GCP guidelines and agreed pharmacy clinical trials procedures. 5.2. Critically appraises clinical trials protocols, including amendments, to assess feasibility and ensure all pharmaceutical aspects of … Pharmacy, or relevant postgraduate experience Demonstrates continued professional development or equivalent knowledge through extensive experience Awareness of Good Clinical Practice (GCP) Desirable Attendance at relevant regional and national Clinical trials courses/meetings Member of relevant specialist pharmacist group Current GCP certification. Teaching/Mentoring more »

at Cambridge University Hospitals. The Data and AI Research Governance Coordinator is responsible for providing expert advice for a portfolio of research involving NHS clinical informatics and AI across a wide range of specialties, throughout the life course of the research project. The post holder will assist with the … initiative. We are an inclusive department and offer flexible working arrangements. Main duties of the job This post does not involve directly working with clinical data. The role holder will provide advice and support to researchers in all aspects of data and AI research governance, including submitting applications to … Knowledge and understanding of research funding streams and award bodies Qualifications Essential Educated to degree level or equivalent experience Desirable Post graduate research qualification GCP Trained Skills Essential Excellent communication skills Excellent organisational and planning skills Excellent interpersonal skills including the ability to build working relationships with department colleagues, Trust more »

enthusiastic, self-motivated, organised quality professional with a keen eye for detail. Some previous experience (ideally between 1 - 2 years) of working in a GCP regulated environment or in a quality environment in a clinical trial organisation is desirable. Day to day, you will oversee the Companys quality systems more »

Company description: QA Director Audit & Inspection GCP-CDCS 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 … process improvement initiatives What we offer: 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 »

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 »

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 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 »

Are you already working in a GLP/GCP environment and want to consider Quality Assurance as your next career move? Do you want to be part of a company that helps build a healthier and safer world? Are you looking for industry recognised training and development opportunities? Labcorp is … equivalent Life Science experience) Experience may be substituted for education Skills/Experience: Proven work history in a regulatory environment working to GLP/GCP Ability to apply basic relevant regulatory knowledge Ability to follow instruction e.g. QA documents (SOPs) Ability to assimilate/interpret operational documents such that audit more »

Job summary The Liver clinical trials team at King's are inviting applications for a clinical trials data manager to work alongside the clinical trials team on an exciting portfolio of commercially funded and investigator led studies in liver diseases. The successful applicant will be an enthusiastic … . Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials. Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations. Liaise with and assist the medical team/sponsor organisation … . Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials. Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations. Act as a resource and support to patients and their 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 »

Senior Clinical Biochemist STATUS: Full Time LOCATION: Onsite in Yorkshire, England DEPARTMENT: Laboratory SCHEDULE: Tuesday to Saturday; Day Shift SUMMARY As a seasoned Scientist IV in Clinical Biochemistry, you will play a vital role within our Laboratory team. … Your responsibilities encompass the meticulous analysis of clinical samples across automated and manual platforms, adhering strictly to Good Clinical Practice (GCP) standards. Joining our esteemed international organization offers more than just a job — it's an opportunity for professional growth and development. Supported by visionary leadership … empowering you to shape our organization and chart your career trajectory. ATTRIBUTES: • BSc in Biomedical Sciences or equivalent. • Minimum of 6 years' experience in clinical biochemistry. • Proven expertise and proficiency in assays/platforms within the laboratory setting. KEY RESPONSIBILITIES Analysis: Conduct thorough analysis of clinical trial samples more »

Desirable *Appropriate professional qualification or knowledge of legal procedures and contracts gained through experience Experience Essential *Understanding of Good Clinical Practice (GCP) and the EU clinical trials directive *Knowledge of Common law of Confidentiality, Data Protection Act 2018 and GDPR. *Experience of report writing and managing …/analysing complex data. Desirable *In-depth understanding of clinical research and trial management methodology, including applicable regulatory requirements. *Significant Operational management experience working within a NHS environment working with clinicians and other health care professionals at all levels of the organisation *Writing Data Protection Impact Assessments (DPIAs) *HR … of normal office hours; *Ability to travel across all of UHB sites and to external sites if required. Desirable *Ability to propose changes to practice and lead on service development for specialist area, developing and implementing policy for that area. Propose changes in conjunction with service groups which have 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 »

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 »

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 »

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 »

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 »

inclusive of sample preparation, data acquisition and processing, and generation of development reports. ATTRIBUTES: A minimum of 3 years of study management experience in clinical and/or preclinical studies Strong background knowledge of … large molecule analysis in support of PK and PD studies. Experience working in a regulatory environment, managing studies that are compliant with GLP/GCP Experience in a client facing role with the ability to provide high level advice and guidance to clients Non-Smoker: due to the nature of more »