1 to 25 of 59 Good Clinical Practice Jobs in the UK

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

standard. Main duties of the job To be responsible for supporting the delivery of the PMU Clinical Trials service within the GMP and GCP legislative framework. To provide expert input into all aspects of the Clinical Trial process from liaising with Sponsors, set up and manufacture of IMP … to ensure a safe and efficient service. To ensure that all IMP activities undertaken within the Production Unit comply with GMP/GDP/GCP, Health and Safety and COSHH legislation and that all work documentation and procedure manuals meet these regulations. To support senior staff in the day-to … they undertake. Clinical trials To lead on the set-up and implementation of Clinical Trials requiring preparation or manufacture to ensure GMP, GCP, full protocol, CTA, and IMPD compliance. To generate quality technical agreements, commercial and supply agreements in response to acceptance of a clinical trial, liaising 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 »

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 »

you'll benefit from a scale of opportunity that is nothing short of extraordinary. We've also created a digitally enabled organisation to improve clinical quality, patient & staff experience, operational effectiveness & driving research, and innovation through the introduction of Hive; our Electronic Patient Record system which launched in September … this post but the post-holder will work closely with Partner organisations across the BRC and from across Greater Manchesters R&I academic and clinical ecosystem. The NIHR Manchester BRC works closely with other NIHR infrastructure in Greater Manchester including the NIHR Manchester Clinical Research Facility, NIHR Manchester … delivery. Experience of analysing complex data to assess risk and monitor progress against plans, managing deviations and issues appropriately to ensure successful project delivery. GCP trained Comprehensive IT skills (including MS Word, Excel, Powerpoint, databases, Internet and email). Ability to influence and negotiate with different professions and organisations and 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 »

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 »

you to have: BSc/MSc/PhD in Chemistry (or related scientific discipline) A sound working knowledge of relevant quality standards; GMP, GLP, GCP and other analytical related quality standards Good working knowledge of Quality Assurance in the Chemical and Pharmaceutical Industry Quality Assurance background which includes some … attention to detail Impressive written and verbal communication ABOUT THE OPPORTUNITY You will provide general support to Quality Assurance activities relating to GLP, GMP, GCP, and other similar Quality Systems established to ensure that the appropriate standards and effective working systems and relationships are maintained and where necessary improved. Responsible … for auditing GLP, GCP and GMP plans, raw data, study procedures and related facilities to ensure compliance with current relevant regulatory requirements and internal consistency, Identify and report any areas of non-compliance to both study and facility management. Liaise with key stakeholders, providing them with accurate information and progress 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 »

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 »

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 »

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 »

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 »

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 »

debilitating disease areas. Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. Job Purpose Lead all Clinical Data Management (CDM) lifecycle activities from protocol inception to database delivery for numerous global studies via oversight of multiple vendors and internal/external … database locks. Participates in Service Provider selection, evaluation and management, including reviewing and providing input to scope of work. Coordinates user acceptance testing for clinical databases. Contributes to global and sub functional working groups and initiatives. Responsibilities Responsible for delivery of clinical global study databases and specific study … is an essential part of the position Working as the sole Data Manager within the Team Key skills and experience In depth knowledge of GCP and current legislation. Working knowledge of Medidata Rave ( desirable but not essential) and IBM databases Experience of delivering global clinical studies across different phases more »