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 GoodClinicalPractice (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 GoodClinicalPractice 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 »
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 & GoodClinicalPractice (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 »
East Kent Hospitals University NHS Foundation Trust
us You will join a small pharmacy-based team, where you will help to ensure the standards of GoodClinicalPractice (GCP) are followed and that patients who volunteer to take part in clinical trials feel valued and receive an excellent pharmacy service. You will work … Operating Procedures (SOPs). To prepare invoice requisitions for clinical trial fees and monitor the receipt of income for specific trials. To attend GCP training as required by the Trust and to work to GCP standards at all times. To attend meetings regarding the set up and running of … Level 3 Pharmacy Services, BTEC Pharmaceutical Sciences or equivalent Registered Pharmacy Technician with the General Pharmaceutical Council Accredited Checking Pharmacy Technician (ACPT) qualification Desirable GCP training Skills and Experience Essential Good understanding of Clinical Trials Experience of working in a hospital pharmacy Evidence of working in a team more »
the technical services team at Sheffield Teaching Hospitals. Currently housing 11 pharmaceutical isolators with another 4 due imminently within the cutting edge ATMP/clinical trial facility being developed within Weston Park, prospective candidates have a unique opportunity to be at the forefront of technical services in a large … the country, offering a range of both general and specialist hospital services. We provide nationally commissioned services and expertise in support of Early Phase Clinical Trials, and we are part of a leading national network for the development of cancer drugs of the future (Experimental Cancer Medicine Centre). … in Pharmacy Post-graduate Clinical Diploma or equivalent demonstrable experience. Desirable Independent Pharmacy Prescriber (IPP) status Pharmaceutical Technology & Quality Assurance (PTQA) course qualification. GCP certificate Band 8a - Experience in a Qualified Person (QP) role. Experience Essential Post registration experience of sufficient quality and quantity to enable demonstration of achievement 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 GoodClinicalPractice (GCP) and GoodClinical 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 »
progress research to improve patient care? We are looking for a hard-working, enthusiastic pharmacist who shares our Trust values to join our expanding clinical trials and research team at Mersey Care NHS Foundation Trust. Mersey Care is at the forefront of clinical trials for mental health, putting … of pharmacist as required3.Participation in screening, dispensing and checking of clinical trial prescriptions, and advising others of GoodClinicalPractice (GCP), Good Manufacturing Practice (GMP) and requirements relating to Investigational Medicinal Product (IMP) management.4.To participate in the Trust-wide Out of Hours Medicines Advice … in Clinical Pharmacy, willingness to work towards or equivalent experience Registration with General Pharmaceutical Council Desirable Membership of the Royal Pharmaceutical Society (RPS) GCP training Knowledge/Experience Essential Demonstrable evidence of commitment to self development and CPD Experience of undertaking audit within pharmaceutical services Understanding of how medicines more »
the life sciences industry (CRO, pharmaceuticals, biotechnology, etc). The ideal candidate will possess a deep understanding of GoodClinicalPractice (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 »
Manchester Childrens Hospital. As the Paediatric BMT Data Manager you will be responsible/for the high quality capture, processing and submission of complex clinical data from clinical systems within the Trust, ensuring the data is handled in a timely manner in line with EBMT recommendations. This includes … Operating Procedures (SOPs) with respect to the Data Protection Act, the Freedom of Information Act and ICH GoodClinicalPractice (ICH GCP). To work alongside other Data Managers and Data administrators with the data entry and configuration tasks necessary to support the BMT Electronic Database (Access … Operating Procedures (SOPs) with respect to the Data Protection Act, the Freedom of Information Act and ICH GoodClinicalPractice (ICH GCP). To work alongside other Data Managers and Data administrators with the data entry and configuration tasks necessary to support the BMT Electronic Database (Access more »
s Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high-quality care, clinical excellence, research and innovation. We are among the UK's busiest, most successful foundation trusts. We provide specialist care for patients including heart and … as well as a full range of local hospital and community services for people in Lambeth and Southwark. We have a long tradition of clinical and scientific achievement and - as part of King's Health Partners - we are one of England's eight academic health sciences centres, bringing together … world-class clinical services, teaching and research. We strive to recruit and retain the best staff as the dedication and skills of our employees lie at the heart of our organisation and ensure that our services are of the highest quality, safe and focused on our patients. Job description more »
that we offer, and the successful applicant will work with the Research Governance group to continue to develop our research programme and with the clinical teams on service development and data management projects. Main duties of the job Be a professional role model and research champion for the organisation. … Team: Hospice Care Team Group: Care Reports to: Nurse Consultant Paediatric Palliative Care Hours: 37.5 hours (Split between Specialist PalliAtive CarE (SPACE) team and Practice Education team) 3 days within the hospice, 2 days remote working Level: Band 7 £50,921.91 - £55,184.02 (geographical allowance included) Location: Christophers, Guildford … the successful applicant will be required to work with the Research Governance group to continue to develop our research programme, strategy and with the clinical teams service development and data management projects. This role is able to be offered as a hybrid working pattern with 3 days in the 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 GoodClinicalPractice (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 »
Liverpool, Merseyside, North West, United Kingdom Hybrid / WFH Options
ecruit
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 GoodClinicalPractice (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 »
ability to network and build strong relationships, experience of building and maintaining EPMA systems and a passion to foster integration of the digital and clinical workforces will be essential. This post is ideally suited to someone with extensive digital experience, as well as a strong grounding in clinicalpractice, who is motivated by well managed change across traditional professional boundaries. The postholder will lead on all aspects of the digital portfolio including our IT systems and will be supported by a team of well-developed pharmacists, technicians and support staff. You will be a role model … to the development of strategic plans for specific areas of IT (procurement/commerce; digital medicines). Contribute to the development and implementation of Clinical Trials as required. About us All new colleagues can expect to receive a warm and friendly Wirral welcome from the very first time they 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 GoodClinicalPractice (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 »
in the UK. The successful candidate will work within our multi-disciplinary Delivery teams supporting the implementation of our next generation patient-centric remote clinical trial solutions. WHAT WILL YOU DO? You will be an integral part of our testing team responsible for testing our mobile applications and web … e.g., Python, Java, JS,) and experience in YAML An understanding of data validation and verification processes. Exposure to GoodClinicalPractice (GCP) guidelines. Competence in analysing clinical data for consistency and accuracy. Candidates with past experience within in the clinical trial industry will have a … by building data capture solutions people love to use. Designed with patients for patients, the uMotif platform supports data capture for each phase of clinical research across all therapeutic areas. Over 22,000 participants use our applications to track and submit e-consent, symptom, eCOA, ePRO, and wearable device more »
Oxfordshire, England, United Kingdom Hybrid / WFH Options
Practicus
a super exciting pharmaceutical startup client based in Oxford. They are looking for someone to come and drive GoodClinicalPractice (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 »
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 … goodclinical 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 »
oxford district, south east england, United Kingdom Hybrid / WFH Options
Practicus
Associate Director of GCP | Permanent | Hybrid - Oxford | Circa £95k We are currently working on a new Associate Director of GoodClinicalPractice 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 Clinical Specialist Radiographer/Technologist - PET-CT & CT OR Clinical Specialist Technologist - PET-CT London Location: Leaders of Oncology Care (main location) and The Harley Street Clinic Hours: Full Time 37.5 hours per week Shift times: 7.5 hour shifts Monday-Friday Salary: Up to … in particular Radiation Protection and Infection Control To assist with patient bookings and administrative duties where necessary To support departmental audits in accordance with clinical governance policies To ensure that quality assurance of equipment is carried out in line with departmental policy, recording and report faults in a timely … To assist with the implementation of new policies within the department and monitor their effectiveness To maintain a high standard of patient care through goodclinical practice. About us At The Harley Street Clinic and Leaders in Oncology Care, we provide a range of complex care services, specialising more »
Job summary The post holder will lead the provision of a high quality, safe and effective pharmacy clinical trials service, to ensure compliance with the required National Standards and UHBResearch and Development Strategy. The post holder will be the Pharmacy Lead Facilitator for Research and Audit projects. They will … own professional actions and deliver a high quality specialisedclinical pharmacy service to promote the safe, rational and cost-effective use of drugs,through personal practice and the training of other staff. The post holder will contribute to the training and education for Undergraduate HealthProfessionals and Post-Graduate Pharmacists, Nurses … Health Board's Research & Development department and, supported by our highly experienced Senior Pharmacy Trials Technician, will provide expert regulatory knowledge with regards to GCP and pharmaceutical aspects of clinical trial delivery and management. The ideal applicant will be a highly motivated and methodical pharmacist who is able to 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 … goodclinical 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 »
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 »
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Job summary An exciting opportunity has arisen for a well-motivated and enthusiastic Pharmacy Technician to join the Pharmacy Clinical Trials Team within Newcastle Hospitals Hospitals NHS Foundation Trust. You will have some level of managerial experience and be able to make on the spot decisions to enable the … responsible for the operational management and organisation of the pharmacy clinical trials service within the hospital site(s) involved. Ensuring compliance with ICH-GCP guidelines, clinical trials regulations, the research governance frameworks and other relevant guidelines and policies To develop, review and revise clinical trials documentation to … the service, we will do our best to make it work for you. Person Specification KNOWLEDGE Essential Up to date knowledge and understanding of GCP,GMP and its application Evidence of preparing worksheets/procedures Knowledge and understanding of the Law and Ethics relating to the dispensing of medicines. Working more »
Proclinical is seeking a dedicated individual for the role of Associate Director, Clinical Data Management. The successful candidate will be responsible for leading the team and overseeing the execution of clinical trials. Responsibilities: - Organise and conduct team meetings. - Foster team development and identify high-performance team members. - Collaborate … with the (Senior) Director Clinical Data Management on team development. - Provide guidance to project teams on the oversight and supervision of CRO/third party vendors and organize trainings as needed. - Act as a mentor for new team members. - Contribute to the development and review of portfolio documents (includes … Clinical Data Management with a focus on DM activities as a Lead and DM project management. - In-depth knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects. - Experience with Clinical Database Systems and processes. - Proven experience in resource planning. - A background in natural more »
ERP) systems, such as SAP. 3+ years of experience sourcing process execution. Experience in working in a regulated environment (e.g. GDPR, SOX, HIPAA, CLIA, GCP, and FDA). Knowledge of other European languages (French, German, Italian, Polish, Spanish) and/or Japanese. Our success relies on the experiences and perspectives more »