1 to 15 of 15 Permanent Good Clinical Practice Jobs with Remote Work Options

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 »

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 »

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 »

capability for the handling of dangerous human pathogens and animal modelling of infectious diseases. The capability is used to understand pathogenesis and undertake pre-clinical development and assessment of new vaccines and therapeutics. The capability is also used to undertake studies in microbiological aerobiology, decontamination, and detection, and to … commercial projects on behalf of vaccine manufacturers. The Group has extensive experience in assay development and validation and operates to several Quality Systems including GCP, GLP and GMP. Main duties of the job Job description The purpose of this job is to perform routine duties related to and to provide … placements, or taught course Experience or understanding of working in a laboratory environment Experience or understanding of working within a regulated environment (e.g., ISO9001, GCP) and safe working practices Desirable Criteria Good knowledge and practical experience with specialist techniques for project i.e., working in a containment level 3 laboratory 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 »

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 »

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 »

HQ 💰 Up to £95,000 per annum 🦸Tech for Good 📈 Seed Funded Startup with thousands of users 📱 Tech Stack: React Native, TypeScript, ReactJS, GCP Play a meaningful, Senior role in building a product from zero to one as this tech for good start up scales from one product … team to many.. Sound interesting?.. This could be for you! I am partnering with a "Tech for Good", seed funded startup with ambitious plans to provide a long term, sustainable solution for one of life's taboo challenges related to sexual wellbeing. The aim being to provide a … large scale, cross platform applications in React Native. The role also opportunities to work across the stack with technologies such as TypeScript, ReactJS and GCP within an agile environment. You'd be involved in the end to end design and greenfield development of a React Native application with a focus 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 »

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 »

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 »

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 »