26 to 50 of 53 Permanent Good Clinical Practice Jobs in the UK

the Quality System by supporting global metrics generation and ‘lessons learned from audit/inspection’ · Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV. · Collaborate with the respective Functional Area Heads/representatives · Collaborate with the respective Global and Regional Quality Leads and functions · Ensure …/EXPERIENCE · Degree in natural science or equivalent number of years’ experience · Experience in Pharmacovigilance auditing (Qualification as an auditor preferred) · Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation · Expert … knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance · Experience in Monitoring, Quality Assurance and/or Good Clinical Practices · Exposure to inspections COMPETENCIES · Understanding of pharmacovigilance · Understanding of audits and 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 »

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 »

their laboratories engaged in exploratory analysis of patient samples. You will be responsible for: Implementation of the company's quality management system relevant to GCP, including laboratory analysis of clinical samples, external vendor oversight, and training on quality procedures Acting liaison and support for Immunomonitoring and R&D labs … training to laboratory teams and eQMS users Plan and conduct of audits, including internal, vendors, clinical sites, and external laboratories Provide guidance on GCP/GCLP/GLP to clinical project teams You will bring the following: Previous experience in GCP QA role, as well as working in … Clinical laboratories Experience in Biologics, Steriles, CGT, or ATMP is highly desirable In depth knowledge of GCP and GCLP practices and regulations eQMS experience including implementation and administration 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 »

FTC, opportunity to go permanent) Our client a Biotechnology Research company are currently hiring for a Labware Developer who has preferably worked in a GCP, GXP environment. Requirements; Experience with LIMS SQL Skills Understand Lab Processes The client are looking to hold interview ASAP, please apply if this role would 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 »

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 »

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 »

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 »

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 »

research facilitators who will take responsibility for the smooth set-up of research across the trust. The role forms an essential bridge between investigators, clinical teams and funders, building accurate and comprehensive grant application costings and working through timely study set-up and delivery. This role will ensure the … largest acute teaching Trusts in England, we offer learning and development opportunities to help you achieve the career you aspire to. UHS is rated 'Good' by the CQC and in the latest national NHS Staff Survey, we were in the top 10 acute trusts for staff engagement and for … of the set-up or delivery of clinical research in a healthcare setting. Experience of delivery training Evidence of current and on-going GCP training Project management experience Knowledge of research governance and quality assurance systems to ensure safe systems for patients An understanding of current R&D issues 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 »

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 »

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 Title: Project Coordinator Department: Project Management Company: WEP Clinical Location: Hybrid - Chiswick Tower, London, England Do you dream of being part of a team that brings hope to those who need it most? Are you searching for a career that challenges you and allows you to grow as … a professional? At WEP Clinical, we are expanding, and the opportunities for personal and professional development are endless. Our team is committed to providing patients with early access to life-changing medicine every day. We encourage our team to bring their most creative and innovative ideas. Join us today … ensure projects are completed in accordance with client expectations. Assist with project documentation collection and review from investigational sites, ensuring they meet FDA/GCP/ICH requirements. Support preparation of study files based on project scope including maintenance of internal or external document storage systems including Electronic Trial Master more »

of Quality Assurance is to promote a quality culture of continuous improvement to ensure all systems and procedures undertaken are in compliance with ICH-GCP guidelines and other regulatory requirements. Main Responsibilities Ensure Non-Conformances/Incident Reports are reviewed, assessed and approved using the eQMS ensuring it is contributing … to continual quality improvement. Ensure Quality Documents are reviewed for process improvements, are of a high standard in accordance with ICH-GCP, and approved using the eQMS. Ensure external Sponsor audits or Inspections are prepared, hosted including timely provision of document requests, and for any findings CAPAs are raised, reviewed … necessary. Organising QA training for all staff - including distributing workload and monitoring task completion. Qualifications and Experience: At least 6 years of experience in GCP Quality Assurance within the Pharmaceutical Industry. Strong knowledge of Quality Management Systems within the Pharmaceutical industry. Strong knowledge of ICH-GCP and GMP guidelines. Experience more »

Head of Clinical Data - Cambridge/London - Exciting MedTech Start-Up … Permanent + Tech-for-Good + Share options scheme Do 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 … universities Experience working in the NHS Experience working with data policies and GDPR Experience working with medical data contracts such as EHR and PACs GCP trained Great problem-solving abilities Excellent time management and communication skills What’s in it for you 💰: Competitive starting salary Share options scheme Hybrid working 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 »

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 »

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 »

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 »

/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 »

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 »

Job summary Band 3 Clerical Officer (Clinical Trial Assistant) - Clinical Trials Unit, Bristol Haematology & Oncology centre Full time 37.5 hours. Permanent position. We are looking for an enthusiastic and motivated person to join our team within the Clinical Trials Unit at the Bristol Haematology & Oncology Centre. You … range of clerical and administrative duties as part of this post. Previous clerical and administrative experience is essential, along with excellent organisational skills and good literacy and numeracy. You will be I.T. proficient in a number of packages such as MS Word, Excel and Outlook and willing to learn … including cancellation of clinics and alteration of appointment slots as and when required and under supervision of the Administration Team Requesting CV's and GCP certificates, as well as PI oversight where applicable, from Research Personnel on an on-going basis and keeping an up to date record of documents more »