1 to 25 of 41 Good Clinical Practice Jobs in the UK excluding London

our pharmacy department. The successful candidate will have the opportunity to develop expertise in clinical trials procedures, Good Clinical Practice (GCP), and relevant regulations. Banding will be dependent on qualifications and prior experience. With demonstrated competency and continuous professional development, there is a clear and automatic … South (PWDS) Accredited Checking Technician (or equivalent) or willing to work towards this once in post Will complete Good Clinical Practice (GCP) training and willing to maintain certification every 3 years as per Trust Policy once in post Working towards Pharmacy Leadership Programme or equivalent or be … ongoing competence in leadership skills Desirable Completed Pharmacy Workforce Development South (PWDS) Accredited Checking Technician (or equivalent) Completed Good Clinical Practice (GCP) and willing to maintain certification every 3 years as per Trust Policy Completed Pharmacy Leadership Programme or equivalent or be able to demonstrate ongoing competence 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 »

Job summary An exciting opportunity has arisen for a Specialist Clinical Trials & Cancer Services Pharmacist to join the Cancer and Aseptic Services team at ESHT. The successful candidate will lead on a portfolio of cancer & non-cancer clinical trials undertaken … within ESHT. They will appraise all relevant clinical trials & offer pharmaceutical input in accordance with legal requirements & Good Clinical Practice (GCP) relating to the prescribing, handling, dispensing, administration, storage & disposal of investigational medicinal products (IMPs) & non-investigational medicinal products (NIMPs). They will also contribute to … the delivery of a high quality specialist clinical pharmacy service to cancer clinical services. Experience in Cancer &/or Aseptic Services is essential. They will not only have the opportunity to explore & enhance their clinical expertise, but will also be developing management, training & leadership skills. They will more »

providing administrative support on cancer clinical trials, you will work closely with the research team to ensure that data is reported as per GCP standards. You will make sure documentation is regularly updated and will liaise with clinical trial centres and pharmaceutical companies to ensure the smooth running … of cancer research. You will be expected to adhere to appropriate regulations, principles and good clinical practice that ensure high quality research and protect patients. Main duties of the job The post holder will work independently, undertaking administrative responsibilities. They will work closely with research nurses, clinicians … and representatives from pharmaceutical and academic sponsors. The post holder will ensure data is collected and reported in line with good clinical practice and study protocols. The post holder is required to priorities and work on their own; using their initiative on a regular basis and manage more »

trials coordination and data management involving clinical trials or project co-ordination, as well as a good understanding of clinical research, GCP and clinical governance. We are looking for individuals with excellent organisation and communication skills, who can work well both in a team and using … support to the senior R&I management and clinical research staff, and ensure compliance with Trust Policy, Good Clinical Practice (GCP) and all other relevant requirements. About us The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We … Research Nurse Team Leader/Research Manager. Person Specification Qualifications Essential Scientific/Business degree or relevant experience in scientific and medical research. Current GCP certification. Desirable Post graduate certificate in clinical research or other relevant post graduate qualification/experience. Management qualification. Experience Essential Line management experience Significant more »

is to support the clinical research team with all aspects of clinical trials administration, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies. The post-holder will be responsible for supporting the delivery of clinical trials within the Clinical … assigned team, under the guidance of the Clinical Research Nurse Team Leader. Maintain investigator site files and essential documentation in accordance with ICH GCP and Trust SOPs to ensure they are always kept inspection ready. Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety … system. Able to assess and interpret clinical/non-clinical information. Knowledge Essential Knowledge of the clinical trials process. Familiar with GCP guidelines/EU directives Desirable Knowledge of issues relevant to paediatric research. Knowledge of patient information systems. Skills Essential Good organisational skills Good more »

provide medical support to the Early Phase Trials team including consultants, nursing and administration staff by primarily acting as co-investigator on early phase clinical trials. The successful applicant will join a highly … motivated and empowered workforce to increase research capacity and deliver innovative early phase research in compliance with Good Clinical Practice (ICH-GCP) and Trust policy. This is a 10 session non-training post funded through The Clatterbridge Cancer Centre for an initial period of 1 year (potential … to extend to 2 years). The Early Phase Clinical Research Fellow role is suitable for individuals towards the end of, or having completed, their specialist oncology training who wish to gain further experience in experimental medicine and Phase I trials, including first-in-human trials, clinical pharmacology more »

Medicines Administration (ePMA) system at Walsall Healthcare NHS Trust. They will also play a key role in the implementation and ongoing management of all clinical digital systems involving medicines and work closely with the Pharmacy IT, Digital Services, wider pharmacy teams and clinical staff across the Trust to … ensure that clinical digital solutions are developed and maintained to reflect the current and future needs of the organisation. Main duties of the job The post holder will: Support the implementation and further development of an Electronic Prescribing and Medicines Administration (ePMA) system across the Trust, and They will … from system suppliers, the Trust IT department, NHS Digital and other system providers, To maintain own training in Good Clinical Practice (GCP) to be able to fulfill requirements for providing pharmacy input to system configuration and developments. Person Specification Qualifications Essential Masters Degree in Pharmacy (or equiv. more »

further their training in practical procedures such as endoscopy and colonoscopy. The weekly ward timetable includes close supervision by consultants and several opportunities for clinical teaching. The post-holder would be expected to participate in medical audit and research projects. The post holder will be expected to do on … colonoscopy and pH studies. 2. OBJECTIVES OF THE POST As a part of these exciting and unique roles, successful post holder will have following clinical responsibilities Paediatric Gastroenterology The post holder will be involved in the day-to-day management of inpatients, review of day case patients and attend … assessments as part of a research study. They will need to have, or be prepared to undertake, good clinical practice (GCP) training. 3.3 Personal Attributes The appointee will have demonstrable skills in written and spoken English that are adequate to enable effective communications about medical topics more »

of documentation for Ethical Approval and the NIHR CSP and EDGE process To establish trial site files for each trial in accordance with ICH-GCP and research governance. To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the study protocol … Facilitate the secure filing and storage of study documentation in accordance with ICH- GCP and Research Governance and conduct quality assurance of documentation Take responsibility for liaising with clinical trials units/study sponsors regarding data queries and for checking and resolving data queries Have a solid understanding of … the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes Ensure safety data is reported to required 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 »

Sponsors to provide safe and efficient delivery of studies. Working with the unit teams and medical leads to create and maintain a culture of clinical excellence, process improvement, effective leadership and high standards of volunteer/patient care. KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED: A minimum of 4 years … experience working within a Senior Strategic Management role, along with a good understanding of Clinical Operations. A minimum of 7 years’ experience within the field of clinical trials, Early Phase preferred, or relevant clinical setting RGN/RMN or BSc Nursing/Biomedical or BSc … in a scientific field would be highly desirable RESPONSIBILITIES: Departmental operational oversight of business activities at the Early Phase Unit in accordance with ICH-GCP, MHRA Phase 1 Accreditation, MAC SOPs and Study specific protocols whilst optimising profitability by leading the MAC teams to meet/exceed business projections. Lead more »

Clinical Data Manager – £35,000-£47,000 per annum– Liverpool/Hybrid The Role Do you have a keen eye for detail and a knack for ensuring data accuracy? Are you excited about using cutting-edge AI to transform healthcare? MyCardium AI, a rapidly growing company using AI to … revolutionise cardiac MRI analysis, is seeking a highly motivated Clinical Data Manager to join our team in Liverpool. In this pivotal role, you will oversee the collection, management, and analysis of imaging data from clinical trials. You'll ensure data quality and integrity, working closely with a dynamic … clinical data management, ideally in imaging. Experience with imaging data and software (PACS, DICOM). Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Proficiency in data management software and databases. Strong understanding of clinical trials and regulations. Excellent organisation and communication skills. Ability to more »

Career Category Clinical Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s … delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. CLINICAL DATA MANAGEMENT MANAGER LIVE What you will do In this vital role you will responsible for ensuring clinical projects are executed according to … study level non-DM documents for awareness and project level consistency. Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study/vendor level. Lead or participate in the development, review and implementation of processes more »

Quality Assurance Manager - Good Clinical Practice Our client, based in Cheshire are recruiting for a contract GCP QA Manager to join them for a 6 month project. This is an exciting opportunity to join a dynamic company with a great culture. Role: Provide strategic direction for quality … CAPA Process to ensure effectiveness Support the development of a risk based audit programme Maintain network of external audit providers to support CMC, pre-clinical and clinical activities. Support the management, implementation, and maintenance of the Quality Management System to support clinical development … activities. Support senior management in providing direction and leadership to staff to ensure a quality mindset is embedded in the business Requirements: Expert in GCP with working knowledge of GMP 5 years experience in a QA Manager role within a CRO, Biotech or Pharma company Contract: Hours: 3 days a more »

we can offer to our patients. We have close links with our R&D team who have made significant investment into growing our pharmacy clinical trial service. The Clinical Trials Pharmacy team at UHCW are looking for a confident, self-motivated, organised individual with excellent problem solving, time … in study feasibility assessment and study setup including prescription, worksheet and SOP generation. Ensure pharmacy comply with all aspects of EU and UK legislation, GCP, GMP and GDP pertaining to clinical trials. To follow departmental SOPs for storage, handling, accountability and destruction of Investigation Medicinal Products both within Pharmacy … the receipt, storage, dispensing and destruction of IMP is safe and secure according to relevant regulations and legislation. To support the department during MHRA GCP inspections, implementing any corrective or preventative actions required. To participate in updating and reviewing Pharmacy Clinical Trial SOPs (standard operating procedures) as needed. Work more »

Job summary An exciting opportunity has arisen for anenthusiastic and motivated band 4/5 pharmacy technicians to work as part of our pharmacy clinical trials team here at University Hospitals Southampton NHS Foundation Trust. Experience and knowledge of ICH good clinical … practice and being a current holder of ACPT accreditation would be an advantage but is not essential.These permanent posts require specialist training in GCP and IMP management. You will work as a Senior Technician in Clinical Trials Pharmacy and must be committed to providing the highest quality of … specialities. You will be responsible in setting up trials, ensuring that trials run smoothly; this will include accurate record keeping and drug accountability of clinical trials, reviewing protocol specific guidelines and liaising within a multi-disciplinary team. You will need to be able to multitask, possess excellent communication skills 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 »

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 »

systems for Trust Sponsored Research studies from the project outset to the end of study. This involves ensuring the high-quality capture of complex clinical and research data from medical records, research documentation and databases through CRF design and building, staff training, and quality control. Your role will involve … supplies. Contribute to the development and maintenance of REDCap. Read and interpret protocol information and translate into a simplified CRF for use by the clinical teams particularly the safety data capture and reporting. Work with the clinical research delivery team to develop a schedule for clinical data … capture for each clinical trial and to identify the time frames within which this work must be completed, ensuring the data is submitted in a timely manner and that contractual obligations are met. Interrogate data systems in order to support Investigators in analysing and presenting data in the required 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 »

Job summary We are looking for a dynamic and enthusiastic clinical pharmacist, looking to expand their knowledge and experience in clinical trials. If you have not worked in clinical trials before but would like to gain experience, then please apply. You will join a high-profile dedicated … healthcare professionals and other agencies relating to pharmaceutical aspects of clinical trials. To understand EU and UK Clinical Trial legislation relating to GCP, GMP and medicines management and ensure incorporation into the implementation of new clinical trials. To deliver specialist education and training in Clinical Trials … risk assessments. To work with and support the pharmacy team working within clinical trial implementation at UHCW. Assisting the team undergoing statutory MHRA GCP inspections and implement corrective or preventative actions. Assisting the development of policies, guidelines, audits and research relating to the use of medicines and devices within more »

We’re currently recruiting for a Regulatory Clinical Trial Strategy & Submissions Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead/hybrid. The Role: Deliver CTA regulatory … strategies and operations for a designated portfolio of development compounds in specified geographic region. Ensure the submission strategy for clinical trials planned globally are in accordance with the overarching global regulatory strategy and any risks and issues are highlighted to the Global Regulatory Project Team and study teams. Ensure … study deliverables are achieved in accordance with global regulatory strategies and compliance with evolving global clinical trial and company procedures. Primary interface between Company and regulators. Populate and maintain regulatory databases, data collation and tracking of regulatory submissions. Participate in development of internal working procedures. Represent regulatory perspective in 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 »

Senior Director - Clinical OperationsSalary: 100000 - 120000 per annumREF Number: v-100265-1Consultant: Jim GleesonContact: 01438 842973Date Published: 29.04.2024Industry: BiotechLocation: Cambridge, Cambridgeshire, EnglandFunctional Expertise: Clinical Operations/DevelopmentJob Title: Senior Director, Clinical OperationsLocation: CambridgeSalary: 100 – 120KDescription:CK Group are looking for a Senior Director, Clinical Operations … to join a clinical stage biotechnology company in Cambridge.Our Client has established a leadership position in the enzymes field. These enzymes are now emerging as attractive therapeutic targets as they are involved in many disease pathways and pathologies.Working closely with the Chief Medical Officer and Head of Development you … study teamsRequirements:• Extensive clinical operations experience gained in a biotechnology or pharmaceutical company• A relevant life sciences degree• In-depth knowledge of GCP, GMP and GLP requirements• Proven ability to lead the delivery of high-quality clinical studies• Leadership and program management experience• Ideally have experience in more »