1 to 25 of 53 Good Clinical Practice Jobs in England

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 ❯

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 ❯

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 ❯

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 ❯

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Manager, Patient Recruitment & Retention to join our A-team (hybrid*/remote). As a Sr. Manager, Patient Recruitment & Retention at Allucent … PDT scope with other Allucent departments such as Biometrics, Project Management, Consultancy, GCO and study start-up. Leadership: Keeps oversight to ensure compliance to the SOPs and ICH/GCP/regulatory guidelines and best practices as well compliance to the department and project metrics. Where needed, initiates course of action to achieve/sustain compliance and efficiency. Contributes to … will possess: Life science, healthcare and/or business degree. Minimum 8 years of experience in drug development and/or clinical research. Excellent knowledge of ICH/GCP, FDA and country regulations. Strong customer service orientation. Demonstrated professionalism and presentation of a positive image of the company. Demonstrated understanding of applicable medical/therapeutic area knowledge and medical More ❯

Join to apply for the Director, Clinical Data Management role at Kailera Therapeutics 16 hours ago Be among the first 25 applicants Join to apply for the Director, Clinical Data Management role at Kailera Therapeutics At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives … and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do The Director of Clinical Data Management plays a key role within Clinical Development Operations, providing strategic oversight for outsourced late-phase clinical trials. This individual is accountable for ensuring the timely … experience in global and cross-cultural environments is preferred Proven success in managing vendor relationships and functional service provider (FSP) partnerships In-depth understanding of FDA and ICH/GCP regulations and guidelines related to data capture and data management processes; strong familiarity with CDISC standards (CDASH/SDTM), medical dictionary coding, 21 CFR Part 11, and industry best practices 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 ❯

forefront of crafting Tables, Listings, and Figures (TLFs) for analysis purposes. Depending on the project's size and complexity, you may lead programming efforts, ensuring alignment with ICH guidelines, Good Clinical Practices, and regulatory requirements. You'll also have the opportunity to mentor fellow programmers and represent Statistical Programming in meetings with internal and external clients. Are you … using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of: SDTM and ADaM principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and 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 ❯

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 ❯

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 ❯

Quality System, inspection management, regulatory intelligence activities, SOP and WP management, and project liaison activities. This role works in close collaboration with the Head of Global Quality Management of GCP, CSV & GVP, Senior Director of Global Quality Management, and the CSV Audit Lead. Qualifications/Experience Required Degree in natural science or equivalent business experience Several years of experience in … the IT industry, pharmaceutical industry, medical devices industry, Regulatory Authority, or relevant fields, preferably including Quality Assurance for Manufacturing, Pharmacovigilance, Clinical Development, and Computerized System Validation and Data Integrity Expert knowledge of relevant regulations and guidance documents in areas such as CSV, Data Integrity, Manufacturing, Pharmacovigilance, Clinical Development, Medical Devices, IMP management, Regulatory Affairs Experience as a Lead 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 ❯

Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: People Leader All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: We are recruiting for a Clinical Programming Portfolio Lead for our location in High Wycombe The Clinical Programming Portfolio Lead is a highly experienced individual with expert understanding of programming strategies, practices, methods, processes … and contribute to organizational effectiveness, transparency, and communication. Directly contributes to delivery of the J&J IM R&D portfolio through effective leadership and accountability of large or complex clinical development and strategic innovation of programs and projects. In collaboration with Senior departmental leadership, the Clinical Programming Portfolio Lead influences departmental effectiveness acting as a change agent to … years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes) and regulatory guidelines (e.g., ICH-GCP) Project, risk, and team management and an established track record leading teams to successful outcomes. Established track record collaborating with multi-functional teams in a matrix environment and partnering with 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 ❯

a positive, results oriented work environment, modeling teamwork and communicating with team members in an open, balanced, and objective manner. Maintain a working knowledge of applicable ICH Guidelines and Good Clinical 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 providing work direction to staff. Ability to motivate and work effectively with virtual teams within different … use of data standards in 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 packages, training, and development. Expect More ❯

conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other … in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Desirable Skills/Experience: SDTM and ADaM Relational Databases. Good Clinical Practices. Good Programming Practices. 21CFR Part 11 Standards. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. 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 ❯