5 of 5 Permanent Good Clinical Practice Jobs in Berkshire

at IQVIA Get AI-powered advice on this job and more exclusive features. The Risk-Based Quality Management (RBQM) Risk surveillance Lead is responsible driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance … Lead works within a matrix environment and has overall accountability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. The role demonstrates leadership in influencing and improving clinical trial quality through the expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles. … Based Quality Management Robust understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions Knowledge of RBQM IT systems or other More ❯

The services hold a responsibility for implementation and maintenance of digital health systems supporting clinical development activities within the Global Development department. The incumbent will be required to provide subject matter expertise in system implementation, validation, maintenance and issue escalation. In addition, it includes participation in/lead operational strategy projects. The services require to work closely with other … team members to ensure system impact is assessed and mitigation strategies are in place where applicable. A clear understanding on the needs of clinical trials/programs and internal or external stakeholders. • Lead projects and/or workstreams actively engaging team members from start to closure • Use project management tools for lean execution of a project • Analyze and document … support system requirements • Interact with Business and obtain the Business Scenarios. General • Services rendered will adhere to applicable Client SOPs, WIs, policies, all applicable local laws and regulations, ICH-GCP, etc. • Comply with relevant training requirements. • Protect the rights of others; protect privacy and company assets, particularly information as the key asset. • Maintain adequate communication with relevant parties within and More ❯

week ago Be among the first 25 applicants The services hold a responsibility for implementation and maintenance of digital health systems supporting clinical development activities within the Global Development department. The incumbent will be required to provide subject matter expertise in system implementation, validation, maintenance and issue escalation. In addition, it includes participation in/lead operational strategy projects. … require to work closely with other team members to ensure system impact is assessed and mitigation strategies are in place where applicable. A clear understanding on the needs of clinical trials/programs and internal or external stakeholders. Lead projects and/or workstreams actively engaging team members from start to closure Use project management tools for lean execution … support system requirements Interact with Business and obtain the Business Scenarios. General Services rendered will adhere to applicable Client SOPs, WIs, policies, all applicable local laws and regulations, ICH-GCP, etc. Comply with relevant training requirements. Protect the rights of others; protect privacy and company assets, particularly information as the key asset. Maintain adequate communication with relevant parties within and More ❯

eSOURCE Data Acquisition Expertise. The Data Acquisition Expert performs activities relating to the definition, set-up and ingestion of External Data Streams, and related documents and processes aligned with Clinical Trial Protocol defined requirements for data capture. Activities are conducted in close collaboration with Data Managers, Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS) . External data streams … and sensors and other digital data collection technologies. Base Level: Bachelor's degree or equivalent, preferably in Computer Science. Minimum of 3 years' experience managing data in support of clinical research. Experience working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG … or similar. Experience working on clinical trials. Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional. Working knowledge of SDTM. Working knowledge of GCP/ICH guidelines Excellent written and verbal communication in English. Demonstrated experience in working with external data providers within a clinical study setting. Experience developing data transfer agreements. E More ❯

This job description is not an exhaustive list of areas of responsibility as the requirements of the role are expected to change over time. Personal attributes Honesty and trustworthiness. Good character. Clear DBS. Clarity of thought. Disciplined and professional approach to work. Non-discriminatory and non-judgemental practice. What are the benefits?* Enhanced holiday entitlement & Birthday off after … day ago Hammersmith, England, United Kingdom 2 weeks ago Woking, England, United Kingdom 1 week ago Surrey, England, United Kingdom 1 week ago Clinical Development Quality Manager (GCP) Egham, England, United Kingdom 5 days ago Bracknell, England, United Kingdom 2 weeks ago Customer Services Performance Coach - Fixed Term Contract - 12 months Aldermaston, England, United Kingdom 1 week ago We More ❯