University College London Hospitals NHS Foundation Trust
management in science or healthcare having written scientific reports and conveying complex issues in an easily understood way. Having worked in research studies or clinical trials with a knowledge and understanding of goodclinicalpractice and research governance framework would be an advantage. Main duties of … a larger international collaboration, and is based in the UCLH BRC. The postholder will be a member of the multidisciplinary HDScI team, which includes clinical bioinformaticians, experts in statistical genomics, blood cell immunogenicity and randomised controlled trials, clinical haematologists caring for patients with inherited anaemias, and researchers in … support services including critical care, imaging, nuclearmedicineandpathology. Weare committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040. Job description More ❯
UCLH (University College London Hospitals NHS Foundation Trust)
and Development Grade: NHS AfC: Band 4 Contract: Permanent Hours: Full time - 37.5 hours per week Job ref: 309-UCLH-5888 Site: NIHR UCLH Clinical Research Facility Town: London Salary: £31,944 - £34,937 Per annum inclusive of HCAS Salary period: Yearly Closing: 20/02/:59 The … studies. The post holder will ensure high quality data in line with the study protocol, the principles of GoodClinicalPractice (GCP) and the UK Medicines for Human Use (Clinical Trials) Regulations. The post holder will be based across both CRF sites according to the needs … equivalent, with Grade C or above in English and Maths. Knowledge of drug development process and concept of clinical trials Knowledge of ICH GCP Science related degree or equivalent Experience Experience of dealing with confidential information Experience of working with clinical trials Skills & Abilities Ability to make decisions More ❯
London, England, United Kingdom Hybrid / WFH Options
TN United Kingdom
Medical Writing, to drive efficiency and accountability. IQVIA Biostatistics helps interpret and draw inferences from data collected on patients as they progress through a clinical trial and serves as the bridge between data capture and reporting. We have one of the largest Biostatistics departments within the industry of around … needs analysis for complex project or client requirements. Acting as a lead on studies, you will directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines and support the training of new or junior team members. As well as … and coordinating tasks within a programming team In-depth knowledge of applicable clinical research regulatory requirements, i.e. GoodClinicalPractice (GCP) and International Conference on Harmonization (ICH) guidelines Join IQVIA to see where your skills can take you Global exposure Variety of therapeutic areas Collaborative and More ❯
in statistical reporting, along with a proven track record in operational or functional leadership, is required. About the Role Lead SP activities for multiple clinical trials within a program or an indication/disease area. Experience in one of the TA areas: Immunology, Cardiovascular & Metabolic Diseases and Neuroscience is … nurture statistical programmers. Conduct performance appraisal of direct reports, as applicable. Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan). Maintain … conferences or consortiums (e.g. CDISC). Experience: In-depth understanding of clinical trials methodology, regulatory requirements, and GoodClinicalPractice (GCP). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met. BS/MS More ❯
London, England, United Kingdom Hybrid / WFH Options
IQVIA
IQVIA is looking to appoint statistical programmers to utilize the SAS programming language to develop clinical study report materials according to the objectives of a clinical trial for regulatory submissions. Programming and performing related tasks serving the full spectrum of statistical programming needs in our DS3 environment (home … Program quality control checks for source data and reporting data issues Interpret project level requirements and develop programming specifications Write programming code following established Good Programming Practices Program SDTM and ADaM datasets Program to create statistical analysis tables, listing and figures Validate datasets and all statistical outputs per prescribed … gate checks Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines Use and promote the use of established standards, SOPs, and standard methodologies Export data and clinical study report materials Provide training and mentoring to team members and department More ❯
London, England, United Kingdom Hybrid / WFH Options
Magentus Group
Magentus products and services have been at the forefront of delivering health technology for more than 30 years, offering deep expertise across clinical systems, health informatics and practice management. Across pathology, radiology, oncology, maternity, and practice management, we are connecting the health ecosystem and transforming digital healthcare … activities The position may require on-site working across multiple implementation sites in the United Kingdom. Experience: Bachelors Degree in Biomedical Science/relevant Clinical Field or Information Technology field PRINCE2 or APMG qualifications an advantage Change Management qualification will be highly regarded Proven work experience as a Business … process mapping Use of laboratory information management systems A sound understanding of the professional, ethical and legal requirements that underpin the health informatics environment Good understanding of laboratory Health and Safety, CPA, MHRA EU Blood Directive and MHRA GoodClinicalPractice for Laboratories and other relevant More ❯
University College London Hospitals NHS Foundation Trust
management in science or healthcare having written scientific reports and conveying complex issues in an easily understood way. Having worked in research studies or clinical trials with a knowledge and understanding of goodclinicalpractice and research governance framework would be an advantage. The HDScI project … a larger international collaboration, and is based in the UCLH BRC. The postholder will be a member of the multidisciplinary HDScI team, which includes clinical bioinformaticians, experts in statistical genomics, blood cell immunogenicity and randomised controlled trials, clinical haematologists caring for patients with inherited anaemias, and researchers in … care, imaging, nuclear medicine and pathology. We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040. For further More ❯
The Principal Statistical Programmer works independently with minimal supervision, tracking progress and providing expert technical support to team members. The role involves working on clinical development programs across different therapeutic areas, overseeing CRO programmers, and ensuring high-quality data summaries. Responsibilities include implementing reporting and analysis activities for clinical … programs. Program outputs for HTA dossiers, publications, and exploratory purposes. Understand and process data structures (CDISC or non-CDISC). Follow regulatory guidelines, including goodclinicalpractice and electronic submissions. Contribute to standards creation, maintenance, documentation, and validation. Review and author data transfer specifications for external vendors. … statistical programming. Qualifications Bachelor's degree in computer science, data science, mathematics, or statistics. 7+ years of experience as a Statistical Programmer in a clinical development environment. Expertise in SAS programming and clinical statistical procedures. Extensive experience with CDISC standards and regulatory requirements. Experience supporting regulatory submissions and More ❯
London, England, United Kingdom Hybrid / WFH Options
Worldwide Clinical Trials
who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way … In Patient Recruitment, our mission is to ensure enrollment milestones are met by making it easier for patients and sites to participate in a clinical research study. Drawing on our extensive experience, and in collaboration with our study team, we will develop a tailored recruitment strategy that will focus … on raising awareness of clinical trial opportunities along the patient pathway, effectively communicating with potential participants, supporting clinical research sites, and improving the overall study experience. What you will do Lead, hire, develop, motivate, and mentor Feasibility team members. This can include line and/or functional management. More ❯
tasks such as setting up user access, data extracts and archiving. Designing eCRF screens Assisting as directed in aspects of design and testing of clinical study databases Maintain own training file Responsible for ensuring that work is conducted in accordance with SOPs and the principles of GoodClinicalPractice Undertake other such tasks as might reasonably be requested from time to time by his/her supervisor and to ensure that his/her work is conducted in a co-operative and flexible manner. To participate in overtime as is reasonably required to ensure the smooth … running of the department. Qualifications and experience required for competent performance IT or numerate degree and/or relevant experience Good organisational skills Ability to work to deadlines whilst maintaining quality standards Effective oral and written communication skills Attention to detail and the ability to multitask #J-18808-Ljbffr More ❯
at Syneos Health Project Data Manager Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Description Project Data Manager Syneos Health is a leading fully integrated biopharmaceutical … solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to … belong. Job Responsibilities Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups Coordinate the work of the assigned Data Management/Data Operations team Ensures launch, delivery and completion of all More ❯
Social network you want to login/join with: We are looking for an expert in clinical trial Data Systems and Data Management to join the UKCRC registered Imperial Clinical Trials Unit (ICTU) team as the new Head of Clinical Data Systems (CDS). Imperial Clinical Trials Unit (ICTU) is a UKCRC-registered clinical trials unit that brings together academic, clinical and trial management expertise from across Imperial College London and the Imperial College Academic Health Science Centre (IC AHSC) to deliver world class clinical trials of all phases and designs. Online … costing Knowledge of the research governance, regulatory and legislative framework for EDC systems supporting clinical trials and clinical data management, including ICH-GCP Proven experience in validation of computerised systems Excellent communication and report writing skills. Proven leadership and management skills at a senior level, including ability to More ❯
London, England, United Kingdom Hybrid / WFH Options
Parexel International
environment, modeling teamwork and communicating with team members in an open, balanced, and objective manner. Maintain a working knowledge of applicable ICH Guidelines and GoodClinical Practices. Role requirements: Proven significant work experience in a CRO/Pharma setting (operational or technical). Proven experience in clinical trial systems (e.g., CTMS, EDC, RTSM) with detailed understanding of requirements gathering, documentation, configuration, and integrations. Knowledge in clinical research industry, including detailed understanding of clinical technology, design, and system requirements. Proven record of influencing a team to deliver according to a schedule. Experience of mentoring or … clinical trial environment. Client focused (internal and external) and demonstrating an ability to create and maintain trust with clients. Knowledgeable in ICH and GCP regulations in relevant geographies. A little about us: Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program. We offer competitive financial More ❯
brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board. About us The King's Health Partners Clinical Trials Office (KHP-CTO) is a collaboration between King's College London, Guy's and St Thomas' NHS Foundation Trust, King's College Hospital … Foundation Trust and South London and Maudsley NHS Foundation Trust. It is set up to provide a single interface for those wishing to conduct clinical trials within the partner institutions, and to ensure that there are common, efficient processes for the set up and administration of clinical trials … in the NHS/Academic and/or commercial sector 2. Knowledge of clinical trial processes, regulatory requirements for clinical trials and GCP 3. Experience of database design/management, and the handling of sensitive data 4. Experience of clinical trial system implementation in a clinicalMore ❯
your dream job, you'll also be helping to save the planet! THE ROLE We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent … to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver company-wide training as and when required Identify areas where new processes are required Create, review and update … the pharmaceutical industry Good awareness of clinical trial issues, design, and implementation Experience of regulatory submissions and associated industry guidance Familiarity with GCP and regulatory requirements Knowledge of SDTM and ADaM CDISC standards APPLY NOW With the world's eyes focused on clinical trial data, this is More ❯
your dream job, you’ll also be helping to save the planet! THE ROLE We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent … to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver company-wide training as and when required Identify areas where new processes are required Create, review and update … the pharmaceutical industry Good awareness of clinical trial issues, design, and implementation Experience of regulatory submissions and associated industry guidance Familiarity with GCP and regulatory requirements Knowledge of SDTM and ADaM CDISC standards APPLY NOW With the world’s eyes focused on clinical trial data, this is More ❯
London, England, United Kingdom Hybrid / WFH Options
PHASTAR
dream job, but you’ll also be helping to save the planet! The Role We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality while adhering to deliverable timelines. The … the pharmaceutical industry. Good awareness of clinical trial issues, design, and implementation. Experience with regulatory submissions and associated industry guidance. Familiarity with GCP and regulatory requirements. Knowledge of SDTM and ADaM CDISC standards. Apply Now With the world's focus on clinical trial data, this is a More ❯
Overview 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, we help … Statistical Programmer, preferably in the clinical research industry Good understanding of global clinical trial practices, procedures, methodologies and regulatory requirements (e.g., GCP, ICH) Experience with R programming is essential Good working knowledge of the types of risks associated with a study and the impact on key … parameters, such as study timelines Strong working knowledge of statistics and statistical software packages Strong SAS programming skills Good working knowledge of statistical concepts Strong working knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation Strong working knowledge of the development and use of More ❯
sponsor’s submission excellence team as a key contributor, providing hands-on technical eSUB expertise including guidance, define, reviewer’s guide, for submission of clinical trial data for FDA, PMDA and EMA regulatory agencies. This is a fantastic opportunity to work for a growing CRO that is recognized for … to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver company-wide training as and when required Create, review and update processes and SOPs Take responsibility for study … Programming Experience within the pharmaceutical industry Experience with ISS and ISE Good awareness of clinical trial issues, design, and implementation. Familiarity with GCP and regulatory requirements Experience of programming to SDTM and ADaM standards APPLY NOW With the world’s eyes focused on clinical trial data, this More ❯
PowerPoint) and adaptable to new software packages/web applications Experience in developing and delivering end user training, preferred system training Excellent interpersonal skills Good organisational and time management skills and able to demonstrate flexibility and adaptability Experience working with high volumes of documentation, electronic and paper Good attention to detail for data entry tasks and understanding of Good Documentation Practices A basic understanding of … computer system validation in the pharmaceutical sector Experience and knowledge of working in a regulated environment, specifically with regards to record retention Knowledge of GCP and GMP with regards to QMS activities Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP More ❯
Social network you want to login/join with: Senior Clinical Programmer, united kingdom col-narrow-left Client: ProPharma Group Location: Job Category: Other - EU work permit required: Yes col-narrow-right Job Reference: baae10def8e9 Job Views: 4 Posted: 02.06.2025 Expiry Date: 17.07.2025 col-wide Job Description: For the … Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that … and influence the development of data standards and strategies pertaining to the standards library. Necessary Skills and Abilities: • Understanding of the principles of ICH GCP and regulatory requirements is essential. • Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline More ❯
talent pool, and we will keep your resume for future opportunities. Ascendis Pharma offers positions in various areas such as Research & Product Development, Commercial, GCP & GVP, Medical- and Regulatory Affairs, HR, Finance & IR, Communications, and IT, among others. Please select your preferred department(s) in the application form. Your resume More ❯
Overview As a Manager, Site Engagement Liaison, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. The Site Engagement Liaison Manager is a field based expert who supports the conduct and the patient recruitment of the client global clinical trials … CRO CRA during site visits. This to ensure high quality conduct and execution of the clinical trials according to the protocol and ICH GCP and local regulatory requirements. Closely work together with the Medical Affairs colleagues, eg the MSLs to ensure optimal synergies in the respective site contacts and … international travel. Experience in global clinical trials is a plus Prior experience in Neurology, Auto-immune and rare disease background Knowledge of ICH-GCP and other applicable legislation Ability to quickly understand complex neurological disease areas, treatments and clinical development plans Understand the healthcare therapeutic landscape, patient pathways More ❯
solutions to HTA problems. The successful candidate will work closely with International Value & Access and HEOR teams to shape ways of working for Joint Clinical Assessment in Europe to ensure high-quality deliverables. The Senior Principal Statistical Programmer will be responsible for all statistical programming aspects of several studies … reporting & compliance with timelines. Job Description Key requirements Lead statistical programming activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization. Co-ordinate activities of programmers either internally or externally. Make statistical programming decisions and propose strategies at study … well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures) Experience as Trial/Lead/Project Programmer for several studies or project-level activities, including coordination of team of internal or external More ❯
London, England, United Kingdom Hybrid / WFH Options
Novartis
study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. Coordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other … teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g., as a member of the extended Clinical Trial Team (CTT). Review eCRF, discuss data structures and participate in data review activities as a member of the extended CTT. Comply with … well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, study procedures). Good communications and negotiation skills, ability to work well with others globally Experience as Trial Programmer, including coordination of internal or More ❯