1 to 25 of 52 Good Clinical Practice Jobs in England

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 »

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 »

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 »

Biotech companies, are hiring a Senior Statistician to join their growing team. The role Lead and manage customer projects ensuring high-quality deliverables Analyse clinical trial data and real-world data Support HTA submissions Mentor junior colleagues Requirements 2+ years’ experience as a Statistician Industry experience, ideally working in … in the UK without needing visa sponsorship. Keywords: HTA, health technology assessment, statistician, biostatistician, ITC, indirect treatment comparison, NMA, network meta-analysis, ICH/GCP, SAS programming, R programming more »

and costs are controlled and communicated to appropriate parties. What will you be doing? Communication: Critical review and documentation with external and internal regulatory, clinical, and marketing experts, including clinicians to determine an appropriate path for product development. Ability to communicate and critically review scientific ideas effectively in written … R&D developments. Regulatory Intelligence: Maintaining awareness of existing and new legislation/guidance relating to ensuring developments comply with GMP/GDP/GCP and GXP, HMR, MDD and MDR where applicable. Quality Policy: To maintain an awareness of, and compliance with the company Quality policy and objectives, and … R&D sample requests. The Person Life Science Graduate Related Experience BSc, MSc, or PhD (MBA desirable) Experience in a related field (e.g., manufacturing, clinical, regulatory or R&D). Specialist knowledge: Niche Generics. Why join us? As well as a fantastic, inclusive company culture, where employees are truly 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 »

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 »

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 »

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 »

Director, Clinical Research Physician (CNS) Our client is a Biotech company with a focus on neuroscience drug development with early-stage and late-stage clinical studies, now have approval for a Director, Clinical Research Physician role working within the Clinical Science team. This hire will work … closely with a multidisciplinary team including biostatisticians, regulatory affairs, clinical operations and data management, toxicologists, pharmacovigilance, medical affairs, market access, etc as necessary. This hire will be based in the UK, working remotely from there. As a medical expert, you will provide oversight and leadership on clinical study … Neuroscience, etc. is preferred. 5+ years of relevant clinical research/clinical development experience across broad therapy areas, working to ICH/GCP guidelines in the biotech or pharmaceutical industry, or clinical setting is preferred. Experience in contributing to clinical study design, clinical protocol development 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 »

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 »

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 »

knowledge of the Research Governance and Legislative Framework for conducting research for Health and Social Care and other relevant national and international guidelines for Good Clinical Practice/Specialist knowledge of the UK wide systems and structures for the approval, management and monitoring of research in the … Microsoft Word, Excel, Outlook and Visio so that coherent plans and documentation can be produced Knowledge and experience of data collection requirements according to good clinical practice Experience of writing reports, business cases, analysing and presenting information suitable for Senior Management and Executive Teams Employer details Employer more »