1 to 25 of 52 Good Clinical Practice Jobs in the UK

Lead Quality Advisor, Clinical Supply Quality Location: UK (Macclesfield) Type: Permanent Competitive Salary & Benefits Be proud to play a significant role to bring safe and effective new medicines to patients. We are adventurous, agile and pragmatic to enable our business to use innovative solutions and technologies to supply clinical trial materials to patients. Business area In the Clinical Supply Quality Team, we are responsible for quality in the development of new Clinical Trials and collaborations and the supply of Investigational Products to them. With a portfolio encompassing both small and large molecules, combination products and ground … and delivery. This may include all Quality aspects of projects including IT projects. Support Clinical Supply functions in GMP inspections and input to GCP inspections where required Approve Clinical Supply GMP documentation Contribute to release and other routine activities required in the clinical supply chain Support quality 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 »

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 »

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 »

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 »

Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies. May perform safety reviews of clinical trial protocols, Investigator’s Brochures, clinical study reports, informed consent forms, and other study related documents. Participates on Global Patient Safety (GLPS) teams … World Education & Experience BA/BS or advanced degree in life sciences or related field with some experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Or PharmD or PhD in a scientific field. Knowledge & Other Requirements Demonstrated ability to be a fast learner. … Knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and standards of Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP). Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly-matrixed more »

interventional studies under your supervision according to agreed resources, budget and timelines complying with AstraZeneca Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. You will accountable for the performance of the Oncology sites selected; ensure that Oncology study sites are identified, qualified … assigned to the clinical trials. You will oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines. As the SMM Oncology Lead, you will be part of the Oncology SMM Leadership Team and line manage a dedicated group(s) of staff. … for national and international travel. Desirable for the role Very good knowledge of the Clinical Study Process, Procedural Documents and international ICH-GCP guidelines. Excellent knowledge of the Monitoring Process. Good understanding of the Study Drug Handling Process and the Data Management Process. Good knowledge of 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 »

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 »

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 »

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 »

R&D team to cover a 12 months maternity leave vacancy. You will work alongside a colleague to manage patient data relating to the clinical research outcomes of patients cared for with Metabolic disorders. You will be involved in all aspects of clinical trials, including research study set … roles and when that happens we sometimes bring the closing date forward, so please apply promptly to avoid disappointment. Person Specification Qualifications Essential NIHR Good Clinical Practice Trained A Degree or Equivalent experience within Research Knowledge & Nature of Experience Essential Previous experience in setting up and coordinating … in the NHS Practical knowledge of the governance and legislative framework for conducting clinical research studies, including Good Clinical Practice (GCP) Desirable Previous experience in Research Grant/Commercial study costing processes Knowledge of the Data Protection Act in relation to research and clinical care more »

ensure correct data collection 3. To be responsible for forwarding trial data in a timely manner to the trial co-ordinating centre. Liaise with clinical trial personnel outside the hospital as necessary. 4. To assist in the review of trial protocols and identify resource implications for the site. 5. … To check eligibility of patients into trials and to ensure that all relevant data has been recorded 6. To take responsibility for liaising with Clinical Trials Units regarding data queries and for checking and resolving data queries 7. To contribute to the development of clinical and research policies … assist with where appropriate the establishment and maintenance of trial site files for trials in accordance with ICH good clinical practice (GCP) and Research Governance 10. To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the protocol more »

coordination all clinical trial functions within aseptic services to meet the needs of the service. Ensure compliance to procedures and national standards (GMP, GCP and The Medicines for Human Use (Clinical Trials) Regulations 2004). About us Cardiff and Vale University Health Board is one of the largest … communication and interaction skills. NVQ L3/BTEC Pharmacy services Good working knowledge of safe dispensing and aseptic practices Knowledge and understanding of GCP/GMP legislation and QA and its application to aseptic processing Able to demonstrate excellent organisational skills Good attention to detail and responsible attitude … quality and accuracy Experience in Clinical Trials day to day running of service, attending meetings, co-ordinating aspects related to organisation of trials GCP/GMP legislation (including preparation for inspection), clinical trial set-up and management, manufacture of IMPs and QP release, clinical trials in specialist 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 »

Associate Director Clinical Biomarkers, Oncology EMU Are you interested in developing, integrating, and implementing innovative biomarker strategies for Oncology clinical development programs, including validation and integration of biomarker assays into clinical trials? If so, the Clinical Biomarker Lead role within Experimental Medicine Unit (EMU) could be … wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will Lead and/or contribute to clinical asset biomarker strategy within early and late-stage clinical development programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action … time. Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms Knowledge and track-record of working to GCP principles. Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment Strong more »

an extremely cutting edge area of the life sciences space. chance to sit alongside the businesses senior leadership team, having full autonomy of the clinical division within the QA department. a small team of quality professionals, supporting with development and training. You will be responsible for: the businesses quality … high standard and aligns with regulations. CQA oversight and support to Pre-Clinical and Clinical Operations. and host regulatory inspections within the GCP remit. You will bring the following: extensive number of years working at a senior manage level within GCP/GLP function. track record of establishing more »

all of the information before applying for the vacancy. Main duties of the job The post-holder will take responsibility for a portfolio of clinical trials as part of our Oncology & Haematology Trials team. This often challenging post will see you working to tight deadlines to transfer data from … participant's clinical records into case report forms. Responsibilities will include liaising with Sponsors, Trust and University staff, preparation of support documentation for the clinical team and maintaining accurate records. You will work closely with the rest of our Multi-Disciplinary Team to provide the best service possible … policy regarding Data Protection - Caldicott Guidelines, Data Protection Act Desirable Good working knowledge of clinical trials and the regulatory bodies to include: GCP, ICH Knowledge of eRecord EXPERIENCE Essential Previous database experience Must be experienced in all aspects of Microsoft Windows applications Previous experience of data management Desirable 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 »

duties of the job Working autonomously, under the direction of the relevant research team leader, the post holder will collate data produced by the clinical teams and enter appropriately into paper or electronic case report forms (CRFs). In addition, the … post holder will liaise with trial sponsors to ensure timely transfer of data, and resolving any data queries, working within the guidelines of ICH GCP and local SOPs at all times. Other responsibilities will include assisting with the creation and maintenance of Investigator site files and databases of clinical … Values Education & professional Qualifications Essential oScience related degree or equivalent oKnowledge of drug development process and concept of clinical trials oKnowledge of ICH GCP Experience Essential oExperience of working under minimal supervision oExperience of working as part of a team oExperience of working to deadlines oComputer literacy to include 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 »

Associate Director Quality Assurance SUMMARY: The Associate Director, Quality Assurance is tasked with implementing strategies to ensure successful delivery of high-quality Clinical Trials studies. This involves driving effective and efficient global processes within the realm of Quality and Operations. This leader collaborates closely with the Clinical Trials … Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) strongly preferred. RESPONSIBILITIES: Leadership. Strategic partnership with Global Quality Assurance team and Global Leadership Team Regional oversight of Quality Assurance teams Daily management activities for … Maintenance of a working knowledge of industry and regulatory standards and requirements Provision of guidance and leadership on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, data privacy, and other relevant regulatory standards Responsive escalation point for Clinical Trials quality issues and 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 »

plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and continuously improving the site's … Qualifications Bachelor’s degree (preferred) 3+ years of experience in a laboratory, pharmaceutical, medical device, or clinical research organization (required) Demonstrated experience in GCP, ISO15189, NEQAS, CAP, CLIA (strongly preferred) Certified Quality Auditor (preferred) RESPONSIBILITIES Quality Assurance Responsibilities: Ensure the efficiency of the Quality System/personnel for the … Act as Deputy Archivist, responsible for maintaining the archive and its contents in compliance with relevant regulations. Introduce systems to comply with revised GLP, GCP, EMA, FDA, and OECD guidelines or regulations. Provide support/host customer-initiated audits, mock regulatory inspections, and regulatory facility inspections. Participate in the review more »