1 to 25 of 45 Permanent Good Clinical Practice Jobs in England

and costs are controlled and communicated to appropriate parties. What will you be doing? Communication: Critical review and documentation with external and internal regulatory, clinical, and marketing experts, including clinicians to determine an appropriate path for product development. Ability to communicate and critically review scientific ideas effectively in written … R&D developments. Regulatory Intelligence: Maintaining awareness of existing and new legislation/guidance relating to ensuring developments comply with GMP/GDP/GCP and GXP, HMR, MDD and MDR where applicable. Quality Policy: To maintain an awareness of, and compliance with the company Quality policy and objectives, and … R&D sample requests. The Person Life Science Graduate Related Experience BSc, MSc, or PhD (MBA desirable) Experience in a related field (e.g., manufacturing, clinical, regulatory or R&D). Specialist knowledge: Niche Generics. Why join us? As well as a fantastic, inclusive company culture, where employees are truly 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 »

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 »

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 »

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 Good Clinical Practice (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 »

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 »

Director, Clinical Research Physician (CNS) Our client is a Biotech company with a focus on neuroscience drug development with early-stage and late-stage clinical studies, now have approval for a Director, Clinical Research Physician role working within the Clinical Science team. This hire will work … closely with a multidisciplinary team including biostatisticians, regulatory affairs, clinical operations and data management, toxicologists, pharmacovigilance, medical affairs, market access, etc as necessary. This hire will be based in the UK, working remotely from there. As a medical expert, you will provide oversight and leadership on clinical study … Neuroscience, etc. is preferred. 5+ years of relevant clinical research/clinical development experience across broad therapy areas, working to ICH/GCP guidelines in the biotech or pharmaceutical industry, or clinical setting is preferred. Experience in contributing to clinical study design, clinical protocol development more »

for this role. The Program Operations Leader (POL) will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations … activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership … team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching 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 »

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 … processes in place. As an experienced CRA you ll be involved in initiation, routine & close out visits for studies in Phases II - IV of clinical development. Successful candidates will enjoy the benefits of working for a company that values a work-life balance. Other Information: This role is a … through Fortrea. For more information please contact Magdalena Koz owska, Recruiter at Magdalena.KozlowskaFortrea.com Key words: Clinical Research, SCRA, Clinical Research Associate, London GCP, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, Oncology, Field Based, Home Based, CRO, Pharmaceutical, London Fortrea is actively seeking motivated problem-solvers and 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 »

About the role ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do … large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP. This position is multi-sponsor and supports medium and … in medicine, science, or equivalent Previous monitoring experience in medium and large -sized studies, including study start-up and close-out Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data Excellent written and verbal communication Ability to work to tight deadlines Availability to travel (domestic fly 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 »

the life sciences industry (CRO, pharmaceuticals, biotechnology, etc). The ideal candidate will possess a deep understanding of Good Clinical Practice (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 »

knowledge of the Research Governance and Legislative Framework for conducting research for Health and Social Care and other relevant national and international guidelines for Good Clinical Practice/Specialist knowledge of the UK wide systems and structures for the approval, management and monitoring of research in the … Microsoft Word, Excel, Outlook and Visio so that coherent plans and documentation can be produced Knowledge and experience of data collection requirements according to good clinical practice Experience of writing reports, business cases, analysing and presenting information suitable for Senior Management and Executive Teams Employer details Employer more »

Proclinical is seeking a dedicated and proactive Director of Clinical Compliance. This role focuses on establishing and implementing a Quality Strategy for clinical development activities. The successful candidate will ensure all work is in agreement with regulatory requirements and will adherence to Good Clinical Practices. This … alternatively can be a hybrid working role based in Mainz, Germany. Responsibilities: Provide strong QA leadership, fostering organizational awareness and interdepartmental collaboration. Implement the Clinical Development Quality Plan within the development portfolio. Provide robust quality oversight in various areas, including risk detection and remediation. Offer guidance on day-to … CAPA preparation. Lead a team to ensure a unified approach to proactive support for clinical trials. Key Skills and Requirements: Experience in a GCP Environment within the Pharmaceutical or CRO Industry. In-depth knowledge of worldwide regulations (including FDA, EMA) related to clinical development and post-approval. Experience more »

lives. Responsibilities: Drive risk-based approach to solve complex business problems. Provide expert input to functional teams in areas such as Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs and Companion Diagnostics. Drive change … Skills and Requirements: Significant understanding within GxP operational and quality roles. Operational experience in at least one of the following areas: Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical, CMC, Clinical Pharmacology, Translational Sciences, Medical Affairs, Commercial, Regulatory Affairs or Companion Diagnostics. Strong and … development and development of medical devices is a plus. Strong knowledge of Clinical Development and Research operations and regulatory landscape. Deep knowledge of GCP, GLP, GPVP, GCP for Labs and a general understanding of GMP. Expert in process development, industry standard problem-solving approaches, in alignment with Lean 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 »

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 »

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 »

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 »

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 »

quality patient care. This post will also be committed to developing the research portfolio and enhancing the national and international profile of the service. Clinical work will be both outpatient-centred in the UCH Macmillan Cancer Centre and involve inpatient attending on a rotational basis. Participation in regional and … working closely with the CAR-T service alongside Dr Claire Roddie, Dr Maeve O'Reilly and Dr Paul Maciocia. There are 3 Cell Therapy clinical nurse specialists (CNS), 3 Lymphoma stem cell/CAR-T CNS and 10 ATIMP clinical trials nurse/practitioners. There is currently one … Participation in clinical audit and attendance at appropriate courses. Research Essential Familiarity with clinical trial methodology Evidence of research activity Evidence of GCP training Desirable Research in relevant clinical field Evidence of first authored publications/peer reviewed publications Disclosure and Barring Service Check This post is 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 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 »

Senior Clinical Biochemist STATUS: Full Time LOCATION: Onsite in Yorkshire, England DEPARTMENT: Laboratory SCHEDULE: Tuesday to Saturday; Day Shift SUMMARY As a seasoned Scientist IV in Clinical Biochemistry, you will play a vital role within our Laboratory team. … Your responsibilities encompass the meticulous analysis of clinical samples across automated and manual platforms, adhering strictly to Good Clinical Practice (GCP) standards. Joining our esteemed international organization offers more than just a job — it's an opportunity for professional growth and development. Supported by visionary leadership … empowering you to shape our organization and chart your career trajectory. ATTRIBUTES: • BSc in Biomedical Sciences or equivalent. • Minimum of 6 years' experience in clinical biochemistry. • Proven expertise and proficiency in assays/platforms within the laboratory setting. KEY RESPONSIBILITIES Analysis: Conduct thorough analysis of clinical trial samples more »