1 to 25 of 56 Good Clinical Practice Jobs

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 »

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 »

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 »

Job summary Senior Assistant Technical Officer - Pharmacy Aseptic Services (Clinical Trials) We have an opportunity for a motivated and enthusiastic person to join our busy Pharmacy Aseptic Services - Clinical Trials Team. Do you have experience of working in a sterile production unit either within the NHS or Commercial … may have just the job for you! We are looking for a Senior Assistant Technical Officer with proven Aseptic skills and experience of dispensing Clinical Trial medications. In return we can offer a rewarding career pathway with the opportunity to undertake a Science Manufacturing Technician -SMT Apprenticeship (Level … in the Principles of Aseptic Pharmaceuticals Processing). Pharmacy Aseptic Services provides a range of sterile medicinal products including Chemotherapy, Total Parenteral Nutrition and Clinical Trial medications Our team is friendly and diverse and devoted to providing safe and timely products for our patients. Our services are an important 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 Good Clinical Practice (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 »

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 »

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 »

Will be the Radio pharmacy expert and professional resource for the multi-disciplinary team. Ensure all Radio pharmacy work complies with statutory regulations and good practice codes; the latter including. The EU Guidance on Good Manufacturing Practice (GMP)/Rules and Guidance for Pharmaceutical Manufacturers and … pharmacy service, organising and implementing complex short, medium and long term plans in response to legislative and regulatory changes, infrastructure developments, evolving consensus of good practice and the availability of new diagnostic tests and treatments. About us Northampton General Hospital is one of the largest employers in the … room design, equipment and function. Understanding of Validation & Quality guidance including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) GCP knowledge and training RPS training Skills Essential Able to prioritise workload/flow of Leaders and team workers, methodical and organised, self-motivated and able 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 »

well established QA function. KEY RESPONSIBILITIES: Coordinating the implementation of the company's quality management system pertaining to Good Clinical Practice (GCP), including oversight of external vendors, training on quality procedures, and performance monitoring against established standards. Serving as the main point of contact and providing support … Supporting the planning and execution of audits, including those conducted internally, at vendor sites, clinical sites, external laboratories, and suppliers. Providing guidance on GCP/GCLP/GLP practices to clinical project teams and identifying/mitigating operational risks and deviations. Overseeing Change Controls, Deviations, and Corrective and … any findings. Delivering training to laboratory teams as needed. Experience Needed: Minimum 4+ years of experience in the pharmaceutical/biotechnology industry in a GCP QA role, with experience in providing quality support to clinical laboratories. Experience in providing quality support for Cell or Gene Therapy programs is highly 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 »

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 »

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 »

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 »

Trial administration duties such as filing, kit inventory, booking couriers, research data entry, data presentation and assist in trial co-ordination in compliance with Good Clinical Research Practice. Main duties of the job To function as a member of the Trials team through provision of dedicated administrative support … to the clinical trials team. Working in a team to co-ordinate data collection for a caseload of patients participating in local, national and international trials in various treatment modalities and disease types. Disseminate information to consultants regarding new trials (including those on the NIHR Clinical Research Network … of the team. Provide support to other colleagues as required. Person Specification Education and Qualifications Essential BSc Life Science degree GSCE standard or equivalent GCP qualification Knowledge and Experience Essential Knowledge and experience with Multidisciplinary team and internal & external stakeholders Previous experience within haematology-oncology; or research Communication and Relationship more »

Job summary The Cambridge Clinical Trials Unit - Cancer Theme (CCTU-CT) is hosted by Cambridge University Hospitals (CUH) NHS Foundation Trust, which includes Addenbrooke's Hospital and is part of the Cambridge Cancer Centre, a partnership between Cancer Research UK, CUH and the University of Cambridge. As the Cancer … Theme of the Cambridge Clinical Trials Unit,we areresponsible for working with investigators to design, set up, conduct, analyse and publish cancer research studies sponsored by Cambridge University Hospital NHS Foundation Trust. The CCTU-CT currently accommodates both early and late phase studies, many addressing or associated with translational … scientific end points. We are seeking a trials data manager to be part of the cancer clinical trials team, which is part of the accredited Cambridge Clinical Trials Unit, to contribute to cancer research. We are looking for candidates with previous data management experience within a research environment. more »

Job summary The expanding Division of Psychology & Psychological Therapies is seeking a clinical and or forensic Psychologist to join our expanding service which now incorporates the learning disability forensic support team in North Derbyshire 37.5 hours/week, negotiable This is an exciting post is seeking a clinical … Psychologists in the learning disability forensic team in North Derbyshire and other multi-disciplinary team and services. We are looking to recruit a registered clinical psychologist who will actively contribute to the service's progression and ongoing development. Main duties of the job The successful candidate must have an … working with adults with learning disabilities and/or autism and experience of service development. You will need to work flexibly both directly in clinical settings and through remote contact with clients, carers and colleagues. You will need to be able to meet the travel requirements of the post 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 »

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 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 »

in a variety of research across numerous specialties. The role is working collaboratively with the clinical team to deliver hosted studies to ICH GCP standards. The successful candidate will be responsible for all aspects of clinical trials data management, playing a key role in the organisation, co-ordination … and execution of all aspects of clinical research data management and administration, including maintaining site files and accurately entering data into case report forms and IT based systems. This role involves working in collaboration with patients, research teams, hospital departments, other NHS Trusts, commercial and academic partners. You will … be required to work across the research portfolio under the supervision of our clinical trials team. Excellent attention to detail, ability to multitask and organise workload are essential skills for this post. There is the opportunity for progression to a Band 3 within this role upon completion of stipulated more »

Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that … assessments, etc.) Other duties as needed. Maintain awareness of and ensure compliance with the Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) requirements, and Good Documentation Practices (GDP). Work in a professional manner with clients, team members and management. Excellent computer skills including Microsoft Word 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 »

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 »

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 »