solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Clinical Data Management Job Category Professional All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description Senior Manager Clinical Data Standards About Innovative Medicine Our expertise in Innovative … while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Senior Manager Clinical Data Standards, within Integrated Data Analytics & Reporting (IDAR), to guide the execution of projects, programs, and processes that span multiple related areas in support of the organisation's overall …/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming Minimum 5 years SDTM experience essential! Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM) Demonstrated written and verbal communications skills Demonstrated customer focus and solution-oriented experience Demonstrated interpersonal skills to build relationships with internal and external More ❯
High Wycombe, Buckinghamshire, United Kingdom Hybrid / WFH Options
Johnson & Johnson
spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: Senior Analytical Monitor x 3/High Wycombe, UK Our expertise in Innovative … of their time for meaningful engagement with sites, driving improved performance, data reliability and site satisfaction. The Senior Analytical Monitor is accountable for executing processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. They typically work with minimal direction from their functional manager. This position collaborates closely with Site Managers … years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry! Knowledge of trial site operations and study execution Strong knowledge of regulatory guidelines (e.g., ICH-GCP). Demonstrated strong understanding of data analysis and familiarity with basic statistical concepts and hands-on experience using data visualization tools Project, Issue, and risk management experience with strong ability More ❯
solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com Job Function Data Analytics & Computational Sciences Job Sub Function Clinical Data Management Job Category People Leader All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description Data Analysis Standards Director About Innovative Medicine Our expertise in Innovative Medicine … step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Data Analysis Standards Director in our Clinical Data Standards (CDS) team to guide and support direct reports in the delivery of the CDS goals and objectives, providing meaningful input for their career development. As a member … least 10 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM) Proven experience in initiating and leading cross-functional projects Excellent written and verbal communications skills Demonstrated leadership in decision making and problem solving More ❯
High Wycombe, England, United Kingdom Hybrid / WFH Options
Johnson & Johnson
today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: Analyst II Analytical Monitor x 2/High Wycombe, UK Our expertise in … of their time for meaningful engagement with sites, driving improved performance, data reliability and site satisfaction. The Analyst II Analytical Monitor supports execution of processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. This position receives ongoing direction from their functional manager and/or other experts to achieve objectives. … years’ experience in Pharmaceutical, CRO or Biotech industry or related field or industry! Knowledge of trial site operations and study execution Working knowledge of regulatory guidelines (e.g., ICH-GCP). Demonstrated understanding of data analysis and familiarity with basic statistical concepts. Project, Issue, and risk management experience with ability to apply critical thinking & problem-solving skills, to drive solutions & helping 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 ❯
TDM services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution … Team, led by the GTL. Ensure inspection readiness through compliance with the clinical research protocol, company Standard Operating Procedures (SOP), codes of GoodClinicalPractice (GCP), applicable regulations and guidelines from start-up through close-out. Takes ownership for assigned responsibilities. Demonstrated competency to act as a backup or first point of contact in absence of … advanced education combined with experience. Req • Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/ More ❯
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 ❯
in building and maintaining stakeholder relationships - Strong experience in quality and compliance management within the life sciences domain, including medical devices and CSV/GAMP5 - Subject matter expertise in GCP, information security, and operational experience in life sciences - Ability to support strategic discussions with the CEO and influence business leadership Experience - Proven track record as a QA Lead in a More ❯
IDAR) organization. The Principal Engineer Digital Health Enablement is responsible for shaping the interfaces between partners, system and process for capabilities administered by Enabling Analytics & System Excellence EASE within Clinical Trial Management Solutions (CTM Solutions) or Investigator & Patient Solutions (I&PS). • The Principal Engineer Digital Health Enablement within CTM Solutions will oversee end to end system planning, administration … oversight and related processes for capabilities supporting clinical trial document management/TMF, study management and oversight. • The Principal Engineer Digital Health Enablement will oversee end to end system planning, administration, oversight and related processes for capabilities supporting patient engagement, site staff enablement, clinical staff training. This includes driving customer enablement and innovative solutions for the supported capabilities … leading inspection-ready practices for the supported capabilities, with a focus on delivering measurable value for stakeholders. • Lead change management efforts, promoting the adoption of new tools and ensuring clinical trial teams are well-equipped to use them effectively. • Remaining connected as a primary point of contact with stakeholders, functional area points of contact and subject matter expert frameworks. More ❯
Reading, Berkshire, United Kingdom Hybrid / WFH Options
IQVIA Argentina
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 ❯
Make your mark for patients Are you ready to shape the future of medicine on a global scale? As Clinical Development Lead , you will play a pivotal role in advancing UCB's most strategic assets-from early-stage development through global registration and launch. This position can be based in Raleigh, NC, USA, Slough, UK or Monheim, Germany. About … the Role As a Clinical Development Lead , you have the opportunity to leave a lasting impact on patients' lives by driving innovative, patient-centric clinical strategies in a highly visible, high-stakes environment. Reporting to senior R&D leadership, you will lead the end-to-end design and execution of global development programs, working cross-functionally to translate … partners. Contribute to corporate strategy , supporting business development initiatives and representing the clinical perspective in asset evaluations. Ensure inspection readiness and regulatory compliance , maintaining the highest standards of GCP and quality throughout program execution. Serve as a global ambassador for UCB , presenting at major conferences, symposia, and advisory forums. Interested? For this position you'll need the following education More ❯
Barts Cancer Institute, Queen Mary University London
initiative – a £43.6M national programme co-led by Queen Mary University of London. PharosAI is set to revolutionise AI-powered cancer care, accelerating the development of breakthrough therapies, advancing clinical applications, and improving access to cutting-edge technology across the UK healthcare and biotech sectors. Read more about the initiative here This is a unique opportunity to help build … mission. You'll be part of a forward thinking, interdisciplinary team building a federated, secure AI platform designed to support NHS delivery, AI-driven drug discovery, and real-world clinical application. You'll also help lead the way in fair, transparent data sharing, patient involvement, and education in AI for healthcare professionals. This is your chance to contribute to … management and significant knowledge of both NHS research governance and quality system management. You will have developed SOPs (or similar) and be familiar with relevant regulations and requirements including GCP, HTA and GDPR. For all our roles we are searching for those who will be passionate about contributing to cutting-edge cancer research and AI-driven innovation, with either or More ❯
Barts Cancer Institute, Queen Mary University London
initiative – a £43.6M national programme co-led by Queen Mary University of London. PharosAI is set to revolutionise AI-powered cancer care, accelerating the development of breakthrough therapies, advancing clinical applications, and improving access to cutting-edge technology across the UK healthcare and biotech sectors. Read more about the initiative here This is a unique opportunity to help build … mission. You'll be part of a forward thinking, interdisciplinary team building a federated, secure AI platform designed to support NHS delivery, AI-driven drug discovery, and real-world clinical application. You'll also help lead the way in fair, transparent data sharing, patient involvement, and education in AI for healthcare professionals. This is your chance to contribute to … management and significant knowledge of both NHS research governance and quality system management. You will have developed SOPs (or similar) and be familiar with relevant regulations and requirements including GCP, HTA and GDPR. For all our roles we are searching for those who will be passionate about contributing to cutting-edge cancer research and AI-driven innovation, with either or More ❯
Barts Cancer Institute, Queen Mary University London
initiative – a £43.6M national programme co-led by Queen Mary University of London. PharosAI is set to revolutionise AI-powered cancer care, accelerating the development of breakthrough therapies, advancing clinical applications, and improving access to cutting-edge technology across the UK healthcare and biotech sectors. Read more about the initiative here This is a unique opportunity to help build … mission. You'll be part of a forward thinking, interdisciplinary team building a federated, secure AI platform designed to support NHS delivery, AI-driven drug discovery, and real-world clinical application. You'll also help lead the way in fair, transparent data sharing, patient involvement, and education in AI for healthcare professionals. This is your chance to contribute to … management and significant knowledge of both NHS research governance and quality system management. You will have developed SOPs (or similar) and be familiar with relevant regulations and requirements including GCP, HTA and GDPR. For all our roles we are searching for those who will be passionate about contributing to cutting-edge cancer research and AI-driven innovation, with either or More ❯