1 to 25 of 26 Good Clinical Practice Jobs in London

be fully integrated into our 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 its continuous learning and development … level resources Attend and input 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 compliance with SOPs and processes … a Science related discipline SAS 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 is a fantastic time to More ❯

not only would you get 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 knowledge of CDISC SDTM and … level resources Attend and input 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 processes and SOPs Take responsibility … discipline SAS Programming Experience within 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 a fantastic time to join More ❯

only will you get your 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 ideal candidate will have excellent … discipline. SAS programming experience within 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 fantastic time to join an More ❯

at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking an Associate Director, Clinical Data Management who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. You'll also play a critical role in the … be responsible for leading and delivering initiatives for CDM within the Biometrics group. You'll also be proactive and be keen to collaborate with cross functional groups within the Clinical Development organization and larger Data Science teams at Recursion. Daily, you will be responsible for all the CDM study activities and deliverables, document reviews, oversight of CRO's, timelines … ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.Proficiency in project management leading 3-4 outsourced programs, simultaneously. Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables. Work with CRO and Recursion functional groups to complete EDC set up More ❯

not only would you get your dream job, you’ll also be helping to save the planet! THE ROLE We are seeking a Principal Programmer to work across multiple clinical and non-clinical studies; Line management skills are a must have, supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable … level resources Attend and input 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 processes and SOPs Qualifications Educated … discipline SAS Programming Experience within 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 a fantastic time to join More ❯

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 based): Responsibilities: Import data from various sources 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 staff You can help us bring clinical trial statistical analysis into the next generation. Award winning and innovative, we will give you More ❯

chance to provide statistical programming 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, a medium to large sized … programming style, quality of statistical 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 or project level. May act … including CDISC data structures as 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 programmers on a given study More ❯

Accountabilities: Lead statistical programming activities as Trial Programmer for several studies or as Lead/Program Programmer 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 or project level. May act … relationships on individual studies with external associates according to agreed contract and internal business guidance. Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures. Your experience: BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences … including CDISC data structures as 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). Proven communications and negotiation skills, ability to work well with others globally and influence. Experience as Trial/Lead/Project Programmer for several studies or project More ❯

of these life-changing treatments. Precision does this by developing assays that utilize biomarkers to help identify the right patient for the right drug. We handle every aspect of clinical trials from initial strategy and design to selecting sites and executing quality clinical trials. The Patient Data Specialist must have a strong working knowledge of medical and oncology …/review trends (e.g., Medical Monitoring, Safety, Clinical Operations, Project Management, Data Management, SAS Programming, Biostatistics, Translational Science, other vendors, etc.) to meet project deliverables in compliance with GCP/ICH, the protocol, oncology standards and applicable Project Plans and SOPs Provides input into project related documentation such as EDC specifications and related completion guidelines, Data Review Guidelines, etc. … Associate (CRA) or Study Coordinator/Research Nurse preferred. Experience with electronic data capture systems (EDC) and data visualization tools preferred Computer proficiency Working knowledge of FDA & ICH/GCP regulations and guidelines. Highly Preferred: Medical related degree, RN, OCN, RPH, PharmD, etc. Knowledge with hematologic malignances Competencies and Skills: Expected to be able to work remotely with the ability More ❯

Microsoft applications, specifically Excel, Word, 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) and is undertaken in accordance More ❯

chance to provide statistical programming 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, a medium to large sized … style, quality of statistical reporting & compliance with timelines. About the Role 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 or project level. May act … including CDISC data structures as 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 programmers on a given More ❯

for a Senior Statistical Programmer to join our Biometrics Department where you will provide programming and statistical support to allocated studies and will be responsible for ensuring that the clinical trial data is reliable and accurate. You will work closely with the Lead Statistician, SAS Programming Study Statistician and will communicate programming related study issues. You will contribute towards … technical leadership within the SAS programming team, ensuring clinical trials are conducted such that subjects’ rights, safety and well-being are protected and is completed within the agreed project timelines. Key Accountabilities Produces and QCs datasets, tables, figures and listings using SAS, including routine statistical analysis. Liaises with Data Management and statistician to ensure the data needed for statistical … the study. Leads on process improvement initiatives within Statistical Programming and plays a key role in reviewing and update SOPs. Maintains knowledge of relevant regulatory guidance and requirements, i.e. GCP, MHRA, CDISC etc. Provides in-house training, technical support and mentoring for colleagues. Provides support to Business Development and attends bid defence meetings acting as the Statistical Programming expert. Performs More ❯

in regulatory activities, and expertise 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 must. Coordinate activities of internal … organizational goals. Recruit, mentor, and 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 up-to-date advanced knowledge … technical programming aspects in external conferences or consortiums (e.g. CDISC). Experience: In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met. BS/MS degree in life science, computer More ❯

either a large/pivotal 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 programmers in functional expertise and … working relationships with cross-functional 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 company, department and industry standards … including CDISC data structures as 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 external programmers on a given More ❯

programming activities for large/pivotal studies or several studies, or act as a Lead/Programmer for a small to medium-sized project in phase I to IV clinical studies. Coordinate activities of all programmers, mentor team members, and make programming decisions at study or project level. Build and maintain effective cross-functional relationships, discussing deliverables, timelines, scope … Your Experience BA/BS/MS or equivalent in statistics, computer science, mathematics, life sciences, or related field. Ideally 5+ years of experience in a programming role supporting clinical trials or in the pharmaceutical … industry. Advanced SAS skills and experience in developing and validating deliverables. Experience with statistical analysis plans and programming specifications. Knowledge of industry standards like CDISC and regulatory requirements (e.g., GCP). Strong communication and negotiation skills, with the ability to work globally. Experience as Trial Programmer and coordinating internal/external programmers. Why Novartis Helping people with disease takes more More ❯

and Requirements: Degree in Computer Science or another relevant field. Experience in SAS programming within the pharmaceutical industry. Understanding of clinical trial design and regulatory submissions. Familiarity with GCP and regulatory requirements. Knowledge of SDTM and ADaM CDISC standards. If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com 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 to accelerate the development of drugs and devices that save … successfully performing the role of 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 standard programs and macros Ability to critically review data and implement corrective action steps effectively More ❯

more exclusive features. Position Overview 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 trials, with a focus … validating SAS (and potentially R) programs. Program outputs for HTA dossiers, publications, and exploratory purposes. Understand and process data structures (CDISC or non-CDISC). Follow regulatory guidelines, including good clinical practice and electronic submissions. Contribute to standards creation, maintenance, documentation, and validation. Review and author data transfer specifications for external vendors. Collaborate with internal and external … and work instructions related to 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 HTA dossiers is a plus. More ❯

Overview As a Principal Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What you will be doing: Develop, review, document and perform validation of SAS programs and macros. Support the development of data repositories, pooling multiple studies Create standard reports in different output formats Automate programming tasks … overengineering software. Is able to demonstrate leadership in development of general purpose tools. Is creative, brings ideas to the table and can perform well when given creative freedom. Display good communication skills, is able … to explain ideas and can also listen well to ideas from others, can be self-critical. Thorough knowledge of and experience with CDISC standards is desired. Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development. Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and More ❯

are required to declare this in their supporting statement. Job overview We are seeking an enthusiastic and diligent researcher to facilitate a mixed-method sub study within a cancer clinical trial. The RADIUS Research Facilitator will be responsible for coordinating the qualitative interview component of the RADIUS study. The RADIUS study will explore how people with the blood cancer … multiple myeloma experience receiving complex information about the genetics of their myeloma and its response to treatment as part of the RADAR clinical trial. The role primarily involves recruitment of people with myeloma enrolled in RADAR for the RADIUS qualitative study and carrying out qualitative interviews. The post holder will be based between UCLH and UCL, working closely with … or social science, arts & humanities or psychology. Use of statistical and/or qualitative data management software. Knowledge of cancer and cancer service provision in England. Knowledge of ICH GCP guidelines. Experience Experience of interpreting complex information. Experience of conducting research. Experience of patient involvement/engagement, and involving patients in research. Experience of setting up/conducting research in 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 at investigative sites, through local and relational support. Responsibilities What … activities such as accompanying the 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 support. Optimize site engagement for … for travel nationally and occasional 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 and investigative sites Excellent communication More ❯

tasks and responsibilities System administration 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 Good Clinical Practice Undertake other … 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 ❯

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 at scale. Driven by our dedicated teams across the globe … standards Assists with pre-sales 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 Analyst or similar in health … of Visio or equivalent for 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 Good Clinical Practice for Laboratories and other relevant regulations and standards Ability to More ❯

experience of administrative or project 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 good clinical practice and research governance framework would be an advantage. The HDScI project, coordinated through UCLH BRC, NHS … of Cambridge, and part 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 Artificial Intelligence & Machine Learning (AI … class support services including critical 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 details/informal visits contact More ❯

Band 4 Main area: Research 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 use of AI is monitored … trials, and experimental non-IMP studies. The post holder will ensure high quality data in line with the study protocol, the principles of Good Clinical Practice (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 and requirements of the busy … Educated to GCSE level or 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 in a constantly changing environment More ❯