1 to 25 of 67 Good Clinical Practice Jobs in the UK

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 »

Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that … programs. Position overview ProPharma are currently supporting one of the global leaders within the life-sciences sector as they require substantial support for their GCP auditing activities. At present, we are currently searching for a freelancer/contractor to work for them on a full-time basis (1.0FTE) remotely with … for 2025. Qualifications required Further education is required to at least a BSc level in a life science or related field Demonstrated background in GCP Quality/Auditing within the Pharmaceutical or Biological industry is a must Fluency in English is a must Ability to travel to sites within the 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 »

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 »

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 »

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 »

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 »

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 »

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 »

Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that … assessments, etc.) Other duties as needed. Maintain awareness of and ensure compliance with the Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) requirements, and Good Documentation Practices (GDP). Experience required A Degree and/or or appropriate relevant work experience. 2 years’ experience working in 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 »

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 »

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 »

Job summary This is an exciting opportunity for a highly driven individual to participate in the development and delivery of the Radiopharmacy quality and clinical service from our state-of-the- art facility at Royal Liverpool University Hospital. The post-holder will be undertake quality assurance and quality control … the Quality Assurance team. The Radiopharmacy at LUHFT is designed to deliver wide range of radiopharmaceuticals for imaging, therapy and investigational medicinal products for clinical trials as well as blood labelling suite. As Senior QA Officer you will help ensure the Radiopharmacy complies with all relevant regulations. You will … knowledge of IRR17 Good practical knowledge or IR(ME)R 2017 regulation Good practical knowledge of Good Clinical Practice (GCP) regulation Good practical knowledge of Radiopharmacy preparation Skills Essential Good verbal skills Good written communication skills Logical thought processes Ability to work more »

Job summary As a member of the Clinical Trials team, you will work closely with other members of the team to ensure that Christie patients have access the latest development of oncology/haematology investigational medicines. The Pharmacy Department are also supporting the large-scale collaborative project alongside several … ensure activities within the pharmacy department are managed in accordance with the International Conference of Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good manufacturing Practice (GMP), the Research Governance Framework for Health & Community Care (2001) and the Medicines for Human Use (Clinical Trials) Regulations … IVRS/IWRS for ordering, acknowledging orders. 4. Dispensing and preparation of medicines both IV and oral clinical trials in accordance with ICH GCP and study specific sops. 5. To provide support to other pharmacy staff in the dispensing of complex clinical trials. 6. Use computer-based data more »

to advancing health through innovative solutions and maintaining the integrity of our processes and products. We are currently seeking an experienced and detail-oriented GCP Auditor to join our team. Job Summary: As a GCP Auditor at you will be responsible for planning, conducting, and reporting on audits to ensure … compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and company policies. Your role will involve auditing clinical trials, vendors, and internal processes to ensure that our clinical research activities are conducted with the highest level of quality and integrity. Key Responsibilities: Plan, schedule, and … conduct GCP audits of clinical trials, sites, vendors, and internal processes. Develop audit plans, checklists, and reports. Identify and document audit findings, non-compliance issues, and areas for improvement. Provide clear, concise, and actionable audit reports to relevant stakeholders. Follow up on audit findings to ensure timely and effective 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 »

Please see the following for the qualifications and skills we seek for this role.Education & Experience MD/Pharm D or other advanced degree in clinical sciences with significant experience working in drug safety/PV or a related field in the biopharma industry, clinical research, health administration, health … policy, or academic or subspeciality medicine. Clinical experience is preferred.Knowledge & Other Requirements Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development).In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies.Strong knowledge of statistical methods used in PV.Proven abilities to make significant contributions to Patient Safety (PS) strategic planning and lead significant process improvements in PS.Exceptional interpersonal more »

only) pathology along with skin pathology. The medical establishment is made up of 10 consultant Histopathologists, with junior support from the deanery rotation and clinical fellow post. The appointee will be based at The Christie and together with colleagues already in post and will provide senior input to all … and out-patients within the hospital, as well as reviewing pathological materials from other hospitals in the North West for cancer patients referred by clinical, surgical, and medical oncologists. The GM-HCDP service (Lymphoma) also receives diagnostic case material from GM Trust and in-house generated samples, with plans … for further onboarding of external GM Trusts. Clinical reporting involves the use of both the local LIMS (TDHC) and the HODS regional LIMS haemato-pathology platform. It is important to note that all neoplastic myeloid pathology is reported elsewhere, so participation in reporting these samples is not required. There 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 »

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 »