Clinical Research

• Serve as the main CTI contact for assigned study sites
• Conduct pre-study, site initiation, interim monitoring, and close-out site visits
• Complete site visit deliverables according to the Monitoring Plan and required timelines
• Assist with or oversee study start-up, feasibility, pre-study activities, and site selection
• Collect, review, and track essential and regulatory documents
• Participate in required training and investigator, client, and project team meetings
• Create and implement subject enrollment strategies for assigned sites
• Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials
• Perform site management activities and provide site status updates to the Clinical Project Manager
• Conduct remote monitoring according to the study-specific Monitoring Plan
• Use systems and reports to track subject status, CRF retrieval/source document review, regulatory documents, and investigational product
• Assist with project-specific activities as a Project Team member

Senior Clinical Research Associate II – UK

• Data analysis and interpretation
• Provide input on data collection methods and coordinate customized electronic database transmissions to Sponsors
• Support the randomization process by generating randomization schedules and randomization plans
• Develop statistical analysis plans for simple to complex studies, including table shells and, when appropriate, other programming plans
• Direct and oversee the execution of planned statistical analysis and summarization for simple to complex studies, including tables, figures, and data listings, independently
• Write statistical methods and results sections of reports for assigned projects
• Review draft reports for consistency and completeness
• Communicate with colleagues and clients regarding timelines, deliverables, and commitments
• Provide programming assistance, as applicable
• Interact with internal departments, including data management and project management
• Lead and/or participate in functions required to ensure success of the department and/or market segment team

Biostatistician

• Hold PI responsibility for almost all Numan RWE studies, including legal, regulatory and ethical accountability
• Lead development and maintenance of study protocols, statistical analysis plans, data management plans and governance documentation
• Oversee study intervention design and delivery with suitable clinical governance infrastructure
• Oversee randomisation, adverse event reporting, protocol deviation management and master file maintenance
• Act as primary contact for funding partners on research methodology, governance and reporting
• Oversee quantitative and qualitative outcome streams and work with data science colleagues on analysis
• Recruit and line manage project-specific staff, including Health Coaches, research coordinators and intervention designers
• Lead or co-lead peer-reviewed publications and drive conference abstracts and presentations at high-impact forums
• Represent Numan as a scientific thought leader with public affairs and PR teams
• Develop and maintain Numan's clinical research strategy and forward pipeline, prioritising oral medication research
• Establish processes, systems and governance to scale research capacity, including study templates, ethics frameworks, data collection standards and publication workflows
• Identify and prioritise research questions demonstrating Numan's real-world outcomes and develop proposals
• Collaborate with data science, product, clinical and behavioural medicine teams
• Act as internal authority on clinical research standards and maintain the clinical research claims library with the regulatory team
• Develop and manage relationships with pharmaceutical companies, academic institutions and public health organisations
• Lead pursuit of external research funding, including NIHR, Innovate UK, industry grants and commercial study partnerships
• Represent Numan at external research events, forums and steering groups
• Report directly to the VP Behavioural Medicine and work closely with Behavioural Medicine, data science and analytics teams

Head of Clinical Research

• Support Phase I-IV clinical studies
• Perform ad-hoc or exploratory analyses to support submissions or Health Authority Questions
• Provide statistical support to clinical studies
• Participate in study protocol development, study design discussions, and sample size calculations
• Review CRFs and data review guidelines
• Develop statistical analysis plans (SAPs), including analysis dataset and TLG specifications
• Perform statistical analyses and interpret statistical results
• Prepare clinical study reports, including integrated summaries for submissions
• Present and explain methodology and the consequences of decisions
• Work fully embedded within and dedicated to a global pharmaceutical client while supported by Cytel
• Collaborate with clinical, regulatory, programming, internal, and external teams

Principal Biostatistician – FSP

• Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits, in accordance with contracted scope and regulatory requirements
• Work with sites to adapt, drive, and track subject recruitment plans
• Administer protocol and related study training to assigned sites
• Establish regular communication with sites to manage project expectations and issues
• Evaluate study-site quality and integrity regarding protocol conduct and regulatory adherence; escalate quality issues
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data-query generation and resolution
• Support the study start-up phase as needed
• Ensure site documents are available for Trial Master File filing and verify Investigator's Site File maintenance
• Create and maintain site-management and monitoring documentation, including visit reports and follow-up letters
• Collaborate with study team members to support project execution

Clinical Research Associate

• Manage all aspects of the clinical trial data management process from study startup through post-database lock for assigned projects
• Follow SOPs/WIs, regulatory directives, study-specific plans, and guidelines
• Serve as primary Data Management contact or Lead DM for assigned clinical projects/programs
• Oversee project data entry, including guidelines, training, quality, and resourcing
• Assess and manage timelines, deadlines, and resource needs
• Develop CRF specifications and coordinate stakeholder review when required
• Conduct database build UAT and maintain controlled database documentation
• Oversee clinical database quality and edit-check specifications
• Create, revise, version, and maintain data management documentation and Trial Master File documentation
• Train clinical research personnel and data management project team members
• Review and query clinical trial data according to the Data Management Plan
• Perform line-listing data review and patient/study-level status and metric reporting
• Perform medical coding and coordinate SAE/AE reconciliation
• Liaise with external data and EDC vendors regarding timelines and data-related deliverables
• Assist with SAS programming and quality control of SAS programs when needed
• Identify and troubleshoot operational problems using metrics, audit reports, and stakeholder input
• Review and provide feedback on protocols, SAPs, and CSRs when required
• Participate in SOP and process documentation development and maintenance
• Support strategy meetings, bid defenses, capability presentations, client engagement meetings, RFP reviews, proposals, and project estimates
• Provide leadership for cross-functional and organization-wide initiatives
• Communicate with sponsors, vendors, and project teams regarding project issues
• Present software demonstrations, trainings, and project meetings
• Perform other assigned duties

Senior Clinical Data Manager

• Manage all aspects of the clinical trial data management process from study start-up through post-database lock for assigned projects
• Serve as primary Data Management contact and Lead Data Manager for assigned clinical projects/programs
• Oversee project data entry, including guidelines, training, quality, and resourcing
• Assess and manage timelines, deadlines, and resource needs
• Develop CRF specifications and coordinate stakeholder review and feedback
• Conduct database build UAT and maintain controlled database-build documentation
• Oversee clinical database quality and edit-check specifications
• Create, revise, version, and maintain data-management documentation and Trial Master File completeness
• Train clinical research personnel and data-management project team members
• Review and query clinical trial data according to the Data Management Plan
• Perform line-listing data review and patient/study-level status and metric reporting
• Perform medical coding and coordinate SAE/AE reconciliation
• Liaise with third-party data and EDC vendors regarding timelines and data deliverables
• Assist with SAS programming and quality control of SAS programs
• Identify and troubleshoot operational problems using metrics, audit reports, and stakeholder input
• Review and provide feedback on protocols, Statistical Analysis Plans, and Clinical Study Reports as required
• Participate in developing and maintaining SOPs and process documentation
• Participate in strategy meetings, bid-defense preparation, capability presentations, and client-engagement meetings
• Review RFPs, proposals, and project estimates
• Provide leadership for cross-functional and organization-wide initiatives
• Communicate with sponsors, vendors, and project teams regarding data and database issues
• Present software demonstrations, trainings, and project meetings
• Perform other duties as assigned; occasional travel may be required

• Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites
• Evaluate site performance and recommend site-specific actions, escalating significant issues and supporting corrective action plans
• Verify informed consent processes are appropriately conducted and documented
• Assess patient safety and clinical data integrity by identifying protocol deviations, violations, pharmacovigilance concerns, and site-level risks
• Conduct remote and on-site monitoring according to the Clinical Monitoring Plan and Study Monitoring Plan
• Perform source document review and verification for accurate, complete clinical data
• Manage protocol deviation reporting, follow-up activities, and resolution of data queries
• Review investigational product accountability, storage, security, dispensing, administration, reconciliation, and documentation
• Document monitoring findings and study activities through monitoring reports, follow-up letters, communication logs, and required study documentation
• Ensure appropriately trained and delegated site personnel perform study activities
• Maintain tracking of observations, action items, site status, and study progress
• Review essential study records to maintain inspection readiness
• Participate in investigator, sponsor, monitoring, and project team meetings
• Collaborate with the primary Site Manager and stakeholders to support study objectives, deliverables, and timelines

Senior Clinical Research Associate – Oncology

• Deliver compliant clinical data and image management activities for commercial clinical study projects
• Perform image (DICOM file) quality control activities, including de-identification and visual screening, in line with work instructions and best practice
• Raise data queries and support external and internal staff in their resolution
• Conduct data reconciliation activities and deliver image and data transfer packages to sponsors and archival
• Support project/study managers in developing and agreeing data and image transfer specifications with sponsors, providing technical input where required
• Conduct user acceptance testing on project-specific configurations of the Qureight Imaging Platform
• Suggest and deliver revisions to work instructions and SOPs as part of continuous improvement
• Work with data engineers to develop improved methods and tools for managing clinical and image data
• Deliver activities on time and to a high standard
• Conduct work in line with Qureight SOPs, Good Clinical Practice guidelines, ISO27001 standards, and data privacy regulations
• Build strong relationships with sponsors, customers, and internal stakeholders through transparent and consistent communication

Clinical Data Manager

• Serve as the technical leader on all data management aspects for projects, including start-up, maintenance, and completion activities
• Develop global Data Management Plans and Quality Management Plans
• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
• Serve as project and client liaison, managing and providing project-specific data management status, cycle time, and productivity metrics
• Coordinate and participate in development of the clinical data model and/or database design and annotate CRFs/eCRFs
• Review data acquisition conventions, data review guidelines, and diagnostic specifications
• Coordinate development and testing of data management system edit/data validation checks, diagnostics, and special listings/procedures
• Collaborate with clinical, programming, statistics, CDM technical support, drug safety, and other project and specialty teams
• Lead advanced planning and risk management, including issue escalation and resource management
• Oversee technical performance of data review project staff and delivery of quality data on time and on budget
• Assist with goal creation and performance review assessments for data review project staff
• Maintain technical data management competencies through internal and external training seminars
• Ensure project staff are trained and adhere to project-specific and global standardized data management processes
• Identify process and efficiency improvements and implement solutions
• Support achievement of project revenue and operating margin targets for data management activities
• Support business development through data management time and cost estimates and presentations to potential clients

Clinical Research jobs in United Kingdom

Senior Clinical Research Associate II – UK

Biostatistician

Head of Clinical Research

Principal Biostatistician – FSP

Clinical Research Associate

Senior Clinical Data Manager

Senior Clinical Data Manager

Senior Clinical Research Associate – Oncology

Clinical Data Manager

Senior Clinical Data Manager – FSO