26 to 50 of 57 Good Clinical Practice Jobs in England

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 »

is also actively involved in NHS, academic and commercial research. The post involves high volume, face to face contact with patients, including those in clinical trials/academic research studies, to acquire clinical data through a wide range of ocular imaging procedures and other ophthalmic assessments, determined either … through standard operating procedures/research protocols or ordered specifically for individual patients by clinical staff. Results are interpreted by clinical staff and inform patient management decisions. The post holder interacts routinely with: patients, administrative, clerical, technical and clinical staff within the Trust and other external stakeholders … the line manager. For a full list of duties, please refer to the attached job description and person specification Person Specification Qualifications Essential Current GCP Certification/NVQ 3 equivalent Up to date professional development plan Desirable Basic level media qualification AOSP Registration Previous technician certification for multicentre/international more »

implement comprehensive quality management strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g. FDA, EMA, etc.) and industry standards (e.g. GMP, GDP, GCP). Provide leadership and direction to the quality assurance and quality control teams, fostering a culture of quality excellence, accountability, and continuous improvement. Establish and more »

implement comprehensive quality management strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g., FDA, EMA, etc.) and industry standards (e.g., GMP, GDP, GCP). Provide leadership and direction to the quality assurance and quality control teams, fostering a culture of quality excellence, accountability, and continuous improvement. Establish and more »

Locum Clinical Research Nurse (Nights only) Thursday, December 14, 2023 Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we helpbiotech and pharma customers save precious time and … patients. As a growing and successful business, we employ more than 1,300talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we … priorityat all times Perform study related procedures such as cannulation, venepuncture, telemetry, holters, vital signs, ECGs, collection of blood samples., in accordance with ICH-GCP Utilise nursing assessment skills to support general well-being of study participants and potential adverse events. Document adverse events and take appropriate action as needed more »

relevant experience.• BA/BS with 10+ years’ relevant experience.• Extensive drug safety or related experience in the biopharma industry, at a regulatory agency, clinical research or related medical/healthcare environment.• Extensive experience in drug safety signal detection, benefit-risk evaluation, and authoring drug safety risk management plans … oversight.Knowledge & Other Requirements• Recognized expert in PV, regulations, signal detection, clinical trials and clinical development.• Expert knowledge of the drug development process, GCP and GVP, including worldwide PV regulations and their application to safety science activities (signal detection,clinical trials and clinical development).• Expert knowledge 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 »

responsibility for duties including: Designs and oversees the implementation quality management systems for CMC development activities including the release of product for GLP and GCP studies. Provides quality expertise in accordance with the global quality requirements in the creation of product characterisation, product specifications, method validation, stability and comparability assessments … in the collaboration with C(D)MOs. Ensures that there are robust processes in place for the review and release product for GLP and GCP studies. Ensures appropriate quality oversight of GMP activities performed by the Product Development teams at Dechra or CDMOs and contract laboratories. This may include review more »

work within the team. The post holder must ensure a high standard of project execution, adhering to research protocols and project proposals across various clinical specialties. This role is both challenging and diverse, working within a growing team that has multiple priorities. The candidate must possess excellent organisational skills … work within the team. The post holder must ensure a high standard of project execution, adhering to research protocols and project proposals across various clinical specialties. This role is both challenging and diverse, working within a growing team that has multiple priorities. The candidate must possess excellent organisational skills … with MS Office (particularly Excel) applications. Understanding and experience of research lifecycle. Understanding of research management systems. Awareness of Principles of Data Protection and Good Clinical Practice. Demonstrate a clear understanding of confidentiality. Experience of working in a busy environment working independently and exercising judgement and decision-making 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 »

Proclinical is seeking a dedicated Manager of Global Trial Optimisation. This role involves overseeing the clinical development strategy, clinical study concepts and protocols as well as operational plans. The successful candidate will play a crucial part in maintaining relationships with external experts to facilitate a wide source of … to meet deadlines, effective use of time, and prioritization. - Ability to influence and negotiate across a wide range of collaborators. - Knowledge of ICH/GCP and regulatory guidelines/directives. - Advanced project management skills, cross-functional team leadership, and organizational skills. - A minimum of a Bachelor's degree and relevant … industry experience. - Direct experience managing global clinical trial operations, including experience developing protocols and key study documents. - Technical proficiency in trial management software and MS applications. Interested or know someone who might be? Reach out to ­­­­Matthew Pike using the following: ✉️ m.pike@proclinical.com 📞 +44 207 4400 639 (5342) Apply more »

research facilitators who will take responsibility for the smooth set-up of research across the trust. The role forms an essential bridge between investigators, clinical teams and funders, building accurate and comprehensive grant application costings and working through timely study set-up and delivery. This role will ensure the … largest acute teaching Trusts in England, we offer learning and development opportunities to help you achieve the career you aspire to. UHS is rated 'Good' by the CQC and in the latest national NHS Staff Survey, we were in the top 10 acute trusts for staff engagement and for … of the set-up or delivery of clinical research in a healthcare setting. Experience of delivery training Evidence of current and on-going GCP training Project management experience Knowledge of research governance and quality assurance systems to ensure safe systems for patients An understanding of current R&D issues 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 »

Trial Master File Expert Our client is a young innovative clinical stage Biotech company with a strong development pipeline, now have approval for a new position for a Trial Master File (TMF) Expert within the Clinical Development and Operations group. There is flexibility for this hire to work … Director of Clinical Development and Operations, this hire will manage TMFs, Sponsor Oversight File (SOF) and Archiving for all studies according to ICH-GCP and other regulatory requirements. This TMF Expert will work closely with Clinical Project Managers across Phase I-III trials, covering multiple responsibilities of outsourced … Science degree is preferred. 10+ years’ experience managing TMFs in Clinical Operations environment, in the pharmaceutical, biotech or CRO industry working ICH/GCP guidelines. Experience in both paper and electronic TMF, and familiarity with naming and filing conventions and the CDISC TMF Reference Model and applicable industry guidelines more »

Proclinical is seeking a dedicated and experienced Senior GCP Quality Auditor. This role is an integral part of the growing global team, contributing to the development and enhancement of audit strategy. The successful candidate will be responsible for conducting and managing audit activities in line with regulatory requirements and company … processes/procedures. Skills and Requirements: Bachelor's degree in a scientific or health-related field. Lead auditor qualification/certification. Experience in conducting GCP audits. Knowledge of regulatory inspections related to GCP is advantageous. Ability to work independently without supervision. Interested or know someone who might be? Reach out more »

Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits more »

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 »

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 »

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 »

/life balance. What we are looking for Life science degree. Extensive auditing experience in GCP. Thorough knowledge of GCP. Able to confidently audit GCP Vendors or Investigator Sites with limited oversight. Strong client focus. What You’ll Do With Us Focusing on delivering top-class audits to our list more »