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 »
Uxbridge, West London, United Kingdom Hybrid / WFH Options
Confidential
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 »
Role introduction: The Director, Clinical Quality will serve as the GCP QA expert within the Compass business and establish strong relationships with other R&D Functions. They will establish, maintain, and ensure effectiveness of GCP QA audit programs and effective GCP systems that support Compass Clinical trials. Location … based in our London office. Reports to: Vice-President, Quality. Roles and responsibilities (include but are not limited to): Support the development of the GCP risk-based processes and frameworks for oversight of vendors and systems Define and build the GCP QA strategy and capability to support Compass clinical portfolio while maintaining a strong independent role for QA decision-making Develop and deliver ongoing fit for purpose GCP training Establish processes and procedures for GCP audit program Manage audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and Compass quality standards Assess impact of 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 »
Maidenhead, Berkshire, United Kingdom Hybrid / WFH Options
Confidential
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 work-life balance. Other Information: This role is a full … employed through Fortrea. For more information please contact Magdalena Koz owska, Recruiter at 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 »
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 »
