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 »
Macclesfield, Cheshire, North West, United Kingdom
Russell Taylor Group Ltd
via literature searches. Providing an indication of any potential difficulties with bioanalytical methods and assisting with client calls and visits. Working to GLP/GCP and showing good documentation practice. The Person A successful candidate will have previous experience working in a regulatory bioanalysis lab with experience performing LC … experience of using LC-MS/MS. Previous experience of troubleshooting Have previous experience performing sample extraction techniques for biological analysis. Must be a good communicator with excellent interpersonal skills. Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this 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 »
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 »
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 »
inclusive of sample preparation, data acquisition and processing, and generation of development reports. ATTRIBUTES: A minimum of 3 years of study management experience in clinical and/or preclinical studies Strong background knowledge of … large molecule analysis in support of PK and PD studies. Experience working in a regulatory environment, managing studies that are compliant with GLP/GCP Experience in a client facing role with the ability to provide high level advice and guidance to clients Non-Smoker: due to the nature of 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 »
Cambridgeshire and Peterborough NHS Foundation Trust
to improve the health and wellbeing of the people we care for, as well as supporting andempowering them to lead a fulfilling life. Our clinical teams deliver many NHS services, not only via inpatient and primary care settings, but also within the community. These services include children's, adult … Qualifications Essential Post graduate qualification in a field relevant to research A degree in law or equivalent qualification Desirable Evidence of continuing professional development GCP Trained Knowledge & Skills Essential Knowledge of clinical research governance Ability to communicate, negotiate and influence effectively as appropriate at all levels and be persuasive … Experience Essential Experience of working with contracts Experience of negotiating contracts in a life science or research setting Desirable Experience of working in a clinical research environment in an NHS Trust, University, pharmaceutical company, charity or other organisation Experience of analysing and interpreting complex contractual terms and/or 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 »
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 »
delivering aspects of care in community settings which supports the Trust's vertical integration strategy. Main duties of the job Duties & Responsibilities The Direct Clinical Care PA's will consist attending on the ward, Neonatal Unit and Children's Assessment unit along with 1 in 10 night on call … to reflect the needs of the department, ensuring that contracted work is appropriately remunerated. An initial job plan review will be undertaken by the Clinical Director after 3 months and annually thereafter, or if the work pattern changes. Any additional PAs contracted by the Trust will be agreed as … higher degree Sub speciality interest in Neurology/cardiology , Acute Paediatrics or Neonatology Management/Audit Essential Participation in research and audit projects Desirable GCP training & Enthusiasm for clinical research Teaching Research/Publications Essential Enthusiasm to teach medical students, junior doctors and other staff on General paediatrics Desirable more »
Biotech companies, are hiring a Senior Statistician to join their growing team. The role Lead and manage customer projects ensuring high-quality deliverables Analyse clinical trial data and real-world data Support HTA submissions Mentor junior colleagues Requirements 2+ years’ experience as a Statistician Industry experience, ideally working in … in the UK without needing visa sponsorship. Keywords: HTA, health technology assessment, statistician, biostatistician, ITC, indirect treatment comparison, NMA, network meta-analysis, ICH/GCP, SAS programming, R programming more »
centre for children's health research with the goal of giving all children and young people the opportunity to participate in, and benefit from, clinical research. The Clinical Research Division works with our clinicians, academia, and industry to invent, develop, and test new treatments for children and young … Premier MRI scanner. The post holder will be required to work as part of a multi-disciplinary team and deliver high-quality research and clinical imaging in the Cross-Sectional service for a variety of paediatric and adult presentations. The post holder must have a flexible approach to the … the demands of the department and of research trial participants. Please see attached job description for further detail. Person Specification Requirements Essential HCPC registration GCP Certificate Degree/Diploma in Diagnostic Imaging Significant experience as a Senior Radiographer Desirable CSI Experience MRI Research Paediatric experience Disclosure and Barring Service Check more »
Liverpool University Hospitals NHS Foundation Trust
involved in NHS, academic and commercial research. The post involves high volume, face to face contact with patients, principally in the glaucoma service acquiring clinical diagnostic data to support and inform clinicians. The post holder interacts routinely with: patients, administrative, clerical, technical and clinical staff within the Trust … date professional development plan Desirable AOSP/ACHS Registration Previous technician certification for multicentre/international clinical trials Member Ophthalmic Imaging Association Current GCP Certification/NVQ 3equivalent Experience Essential Experience in ophthalmic imaging/retinal screening Evidence of recent professional development. Desirable Experience in a commercial photographic environment. 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 »
