Pop Sciencehttp://www.pop-science.co.uk/18202026-04-09 09:01:57https://www.pop-science.co.uk/index.php?option=com_recmgr&view=job&jid=1820&Itemid=98610,000-19,999Temporary / ContractCentral London, UKWe are looking for a contract QA Manager to work with a client in Central London. We need a QA & Compliance Manager to lead and continuously strengthen quality and compliance framework across all project activities. This role is responsible for the hands-on implementation and oversight of the Quality Management System, ensuring compliance with applicable regulatory requirements, industry standards and client expectations. The QA & Compliance Manager will provide practical guidance to study teams, proactively manage risk, oversee audits and inspections and drive continuous improvement across the business. Acting as a key partner to operational teams and senior leadership, the role plays a critical part in maintaining inspection readiness, supporting business growth and embedding a strong quality culture throughout. Key Responsibilities:Quality Management System (QMS) Risk Management & OversightQuality Assurance & Compliance Audits, Inspections & Continuous Improvement Training & Quality Culture Regulatory Intelligence & ReportingData Protection & GovernanceVendor & Partner OversightQualifications and Experience Ideal background:  Strong years of experience in clinical research, including time spent  in Quality Assurance and Compliance within a CRO, pharmaceutical or biotech environment    Demonstrated experience developing, implementing and maintaining a Quality Management System (QMS) in a regulated clinical research setting    Strong working knowledge of ICH-GCP, ISO standards and applicable global regulatory requirements    Proven experience managing clinical audits, vendor audits and regulatory inspections    Hands-on experience investigating quality issues, deviations and non-conformances, including leading root cause analysis and CAPA development    Experience assessing and managing compliance risks related to new services, technologies, or business initiatives    Demonstrated experience providing QA guidance and oversight to cross-functional clinical teams    Prior experience acting as, or supporting, a Data Protection Officer (DPO) role and ensuring compliance with data protection legislation (e.g. GDPR) preferred    Experience developing and delivering quality and compliance training programs   #QA  Clinical Research18212026-04-09 10:58:37https://www.pop-science.co.uk/index.php?option=com_recmgr&view=job&jid=1821&Itemid=98650,000-59,999Permanent Full TimeCentral London, UKWe have a great role for a Clinical Project Manager in Central London. We can consider part-time for these roles sometimes. Our client has an extensive global network of sites they work with to provide clinical trials to a range of sponsors and across various Therapeutic areas, although there is a focus on cardiovascular, haematology and oncology therapeutic areas. If you have some Clinical Project Management experience, working with clients to ensure studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory guidelines, then let us know. This could be perfect for you.   Key Responsibilities: To lead local/ regional study management teams in implementation of clinical trials ensuring the studies are performed and conducted in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory requirements for the allocated studyDefine and monitor project scope, timelines and deliverables from project initiation to close out.  Ensure project plan aligns with contract requirements, and address any reconciliation requiredStudy oversight and status reporting study targets discussed and agreed, includes the development of study timelines, communication, risk and quality plans, team training and oversightSchedule, plan for, and document regularly scheduled project team meetings. Assess project issues, propose resolutions to the project team, management and Steering Committee as necessary, and then track implementation of resolution through to completion.Ensure the overall quality of project services and deliverables by documenting project/clinical trial progress to ensure completeness of documentation and data collection, management of supplies and resources in adherence with the project timelines, budgets and quality standards including central laboratory (if applicable) and contract/academic research organisations.Accountable for status of studyies communicated regularly with study team and management and that unresolved issues are escalated appropriatelyResponsible for maintenance of TMFPreparation of site agreements, contracts, and financial/site payment tracking during study conduct.Protocols developed in conjunction with Chief Operating Officer and InvestigatorsAttendance of and contribution to Investigator meetingsEnsure site and outsourced CRO staff trained in protocol specific proceduresManagement of ethics, regulatory requirements and local applicationsLiaison with external customers e.g. Steering Committees, Investigators, Study Nurses and Clinical Trial Pharmacists etc.To provide the day-to-day operational management of CROs and vendors ensuring delivery against contracted scope of work for the allocated regionPlan and manage study budgetContribute to process improvementAssist with training and with preparation of training material for Study support roles   Desired Skills and Experience: Proven clinical trials project management and leadership experienceLife science or other relevant degreeExcellent Project Management skillsExcellent presentation, communication and organizational skillsGood attention to detailsExcellent interpersonal skills and a good team playerCost and Financial oversightProven ability to develop and update working practicesFlexible and effective project management, communication and negotiation skillsIdeally experience overseeing outsourced CRO workIdeally a strong understanding of cardiovascular disease and treatment is helpful but other therapeutic areas are valuable too #clinicalresearch #clinicaltrials #pharmajobs  #CROjobs #clinicalprojectmanager #clinicaldevelopment #londonjobs #clinicalstudymanagement #SCOPE2022 #decentralizedclinicaltrials #DCT #decentralizedtrialsClinical Research18222026-05-07 11:36:27https://www.pop-science.co.uk/index.php?option=com_recmgr&view=job&jid=1822&Itemid=98610,000-19,999Temporary / ContractCentral London, UKWe are delighted to be looking for an interim Clinical Programme Director to work at our client's site in London. The Programme Director will be responsible for the strategic oversight, delivery and governance of multiple clinical programmes across the company. The role requires hands-on leadership, strong client engagement and the ability to balance operational delivery with strategic planning. Key duties include defining programme scope, setting goals/milestones, managing budgets, leading teams, coordinating resources, mitigating risks and reporting progress to leadership. Our client is a relatively small team so this role is hands on managing studies, as well as leading strategy. A great and varied role!Key Responsibilities:· Strategy & Portfolio Leadership:· Provide strategic oversight of multiple clinical programmes, defining and owning the end-to-end programme vision aligned with business strategy· Translate strategic objectives into actionable, cross-functional delivery plans· Ensure programmes meet sponsor objectives for timelines, budgets, quality, and compliance· Monitor risks, dependencies and milestones, acting as the senior escalation point for complex issues· Client & Stakeholder Management:· Serve as the primary senior contact for assigned sponsors and partners· Build and maintain strong, long-term client relationships based on trust, transparency and performance· Lead or support sponsor meetings, steering committees and programme reviews· Contribute to business development activities including bid defence meetings, proposals and scope development· Operational Oversight:· Provide leadership and guidance to Project Leads, Project Managers and cross-functional teams· Ensure consistent application of SOPs, processes and best practices across all  programmes· Support resourcing strategies, including capacity planning and prioritisation across studies· Quality, Compliance & Risk Management:· Ensure all programmes are conducted in compliance with ICH-GCP, regulatory requirements and internal quality standards· Proactively identify quality and compliance risks and drive corrective and preventive actions· Support audits and inspections, including sponsor and regulatory authority interactions· People Leadership & Development· Mentor and develop both junior and senior clinical operations staff· Foster a collaborative, accountable and high-performance culture· Support performance management, succession planning and talent development initiatives· Budget and Resource Management:· Plan programme budgets, monitor expenditure, and ensure financial resources are utilised within agreed limits· Ensure all programmes are appropriately resourced, with staff, equipment and vendors available and used efficiently Required Qualifications & Experience· Bachelor's degree in Life Sciences or a related discipline (advanced degree preferred)· Significant experience in clinical research within a CRO or pharmaceutical/biotech environment· Proven experience leading multiple clinical programmes or large, complex clinical projects· Strong understanding of clinical trial operations, regulatory requirements and quality systems· Demonstrated success in senior sponsor-facing roles· Strong strategic thinking combined with hands-on operational capability· Excellent leadership, communication and influencing skills· Commercial awareness, including budgeting, forecasting, and change management· Ability to manage complexity, competing priorities, and ambiguity· Strong problem-solving and decision-making skills· Collaborative mindset with the confidence to challenge and escalate when necessary· Appropriate working knowledge of GPP, GCP and the regulatory framework for clinical research Candidates must be experts in clinical research and be able to work at our client's London office 3 days/ week.  #ICHGCP #Clinicaltrials #ClinicalProject #haematologyClinical Research18232026-05-08 08:06:55https://www.pop-science.co.uk/index.php?option=com_recmgr&view=job&jid=1823&Itemid=98610,000-19,999Temporary / ContractCentral London, UKOur client is seeking an experienced Statistical Programmer as a full time contractor for 6-months. The successful candidate will work closely with the Head of Statistics, an existing Statistical Programmer, and the wider research team to deliver on an exciting new project looking at the disease course of Atrial Fibrillation.The primary focus of the role is to support the creation of CDISC-compliant datasets, primarily SDTM and, where needed, ADaM, for an observational real-world study. The successful candidate will be expected to develop programming solutions and dataset specifications in R, based on the protocol, eCRF, and study requirements. Depending on sponsor requirements, the role may also include support for submission-readiness activities and preparation of associated documentation.Key responsibilities· Lead the conversion of raw observational study data into CDISC SDTM datasets and drive the end-to-end development of ADaM datasets.· Develop R code to transform source data into standardised structures.· Review the study protocol, annotated CRF/eCRF, and related documentation to identify dataset and metadata requirements.· Write trial design datasets/specifications, SDTM specifications, and ADaM specifications.· Translate EDC/eCRF structures into detailed SDTM mapping specifications, including derivation and transformation logic.· Prepare and maintain key submission-supporting documents, including:o SDTM Review Guideo ADaM Review Guideo define.xmlo controlled terminology / codelist documentation· Validate datasets and identify and resolve issues using Pinnacle 21 / OpenCDISC.· Contribute to establishing a robust and reproducible programming workflow using GitHub and relevant R-based packages.· Work collaboratively with statisticians, research strategists, and the existing statistical programmer to ensure datasets and documentation are accurate and fit for purpose.· Support preparation of submission packages, if required.· Perform independent double-programming and validation of datasets to ensure adherence to CDISC guidelines prior to sponsor delivery.· Contribute to good programming practice, quality control, and documentation standards across the project.Person specificationEssential experience and skills· Proven experience converting observational / real-world study data into CDISC SDTM and, coupled with deep, hands-on experience generating ADaM datasets and specifications from scratch· Strong hands-on programming experience in R, including building codebases and derivations.· Strong experience with CDISC implementation and submission-supporting documentation.· Experience using R-based CDISC/pharmaverse tools such as:o sdtm.oako admiralo other relevant pharmaverse packages· Experience writing SDTM and ADaM specifications directly from protocol and CRF/eCRF documentation.· Experience converting annotated CRFs / EDC structures into detailed mapping specifications and transformation logic.· Familiarity with preparing define.xml, review guides, and controlled terminology documentation.· Experience validating datasets using Pinnacle 21 or equivalent CDISC validation tools.· Experience using GitHub for version control, code management, and reusable workflows.· Strong attention to detail and commitment to quality and reproducibility.Desirable· Previous experience supporting regulatory submission packages.· Experience in cardiovascular, thrombosis, or other observational registry studies.· Familiarity with biomarker, laboratory, and patient-reported outcome data.· Working knowledge of SAS, although this is not essential for this role.#R #StatisticalprogrammerClinical Research