Clinical Trials

  • Medical Statistician 6/14/2019 12:00:00 AM

    Salary: £0 Location: Oxford

    Medical Statistician - Oxford- Full time- (Office based) Based in Oxford my client is a specialist IT and AI company focused on combining technology and ethically sourced patient data, to increase patient care. To do this, they have created a unique partnership with the NHS that delivers a return to their partner Trusts and unlocks the value of clinical data for research while safeguarding patient privacy. Using proprietary clinical AI technology to analyse ethically sourced, clinically curated, anonymised patient data to solve serious unmet medical needs across a wide range of therapeutic areas, enabling a new approach to clinical trial design, drug discovery, development and post-marketing surveillance. Their current products include vital-signs monitoring in hospitals and patient-to-clinician apps to support self-care and remote monitoring of gestational diabetes and chronic diseases such as COPD and heart failure. Due to continued growth they are looking for an experienced, hands on, Medical Statistician with a strong background in statistical modelling (e.g., longitudinal data analysis, generalised linear mixed models, multinomial models, etc.) for large-scale data analytics and predictive modelling. The Medical Statistician needs to be familiar with statistical programming languages (e.g., SAS, Stata, Python, and R) and will be responsible for data management, data cleansing, data integration, and constructing advanced statistical models to address important questions about risk factors for chronic diseases. This role will work closely with a wider team of machine learning researchers bioinformaticians, computational biologists, programmers and clinical researchers within the company. The successful candidate will provide statistical and programming expertise, and will be actively involved in study design, data preparation and analyses, preparation of reports and presentation of research. MSc or higher in Bioinformatics, Statistics, Health Informatics or another relevant qualification. Experience of working with clinical or medical data. Experience working in in SAS or Stata. Experience in R (will accept candidates who have SAS and show a strong willingness to learn R) Experience in advanced statistical modelling, including longitudinal data analysis and mixed models. BENEFITS Competitive Salary Company share option scheme 5% employer matched Pension scheme BUPA Health Insurance including Partners and Children cover Free Gym Membership Cycle to work scheme A challenging and fun environment that rewards results

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  • Senior Regulatory Affairs Manager 5/17/2019 12:00:00 AM

    Salary: £0 Location: Nottingham

    The Client: My client is a pharmaceutical organisation dedicated to accelerating the drug development of new drugs for patients around the world. They provide formulation development, clinical pharmaceutical trials and clinical and commercial manufacturing services to the pharmaceutical and biotech industry. Their vision is to transform drug development with science and innovation and hence, operate from state-of-the-art manufacturing and clinical facilities in both UK and US. They are currently hiring for a Senior Regulatory Affairs Manager at their site in Nottingham who will act as Regulatory Lead in providing a centralised service coordinating regulatory submissions (CTA applications, ARSAC applications & Research Ethics Committee (REC) submissions) for clinical studies conducted by the company. As the Senior Regulatory Affairs Manager, you will line manage members of the Regulatory Affairs Department, drive continuous quality improvement relating to regulatory processes. Most candidates will have: - Educated to a degree level in a biological or life science - 4 years’ minimum regulatory experience, preferably in a pharmaceutical company or CRO - Project leadership experience would be advantageous - Familiarity with CTA, REC and ARSAC regulatoy submissions - Confident and articulate communicator - Previous interaction with regulatory authorities would be an advantage - Experience in IND and eCTD submissions is highly desirable but not essential In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

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  • Health Informatician 5/13/2019 12:00:00 AM

    Salary: £0 Location: Oxford

    Health Informatician- Oxford- Full time Based in Oxford my client is a specialist IT and AI company focused on combining technology and ethically sourced patient data, to increase patient care. To do this, they have created a unique partnership with the NHS that delivers a return to our partner Trusts and unlocks the value of clinical data for research while safeguarding patient privacy. Using proprietary clinical AI technology to analyse ethically sourced, clinically curated, anonymised patient data to solve serious unmet medical needs across a wide range of therapeutic areas, enabling a new approach to clinical trial design, drug discovery, development and post-marketing surveillance. Their current products include vital-signs monitoring in hospitals and patient-to-clinician apps to support self-care and remote monitoring of gestational diabetes and chronic diseases such as COPD and heart failure. Due to continued growth they are looking for an experienced Health Informatician, with a strong commercial focus, to help Identifying key health informatics problems faced through main stream health care. Working with the company’s VP’s, as part of a cross functional team, utilising the companies state of the art technologies in ML and AI to help bridge the gap between the businesses cross functional teams and industry. PhD in Bioinformatics, Health Informatics or another relevant qualification Experience of working as a data scientist within heath informatics (ideally with in the NHS) sectors Strong commercial understanding. BENEFITS Competitive Salary Company share option scheme 5% employer matched Pension scheme BUPA Health Insurance including Partners and Children cover Free Gym Membership Cycle to work scheme A challenging and fun environment that rewards results

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  • Clinical / Biological Expert 5/9/2019 12:00:00 AM

    Salary: £0 Location: Oxford

    Biological/Clinical lead- Oxford- Full time Based in Oxford my client is a specialist IT and AI company focused on combining technology and ethically sourced patient data, to increase patient care. To do this, they have created a unique partnership with the NHS that delivers a return to our partner Trusts and unlocks the value of clinical data for research while safeguarding patient privacy. Using proprietary clinical AI technology to analyse ethically sourced, clinically curated, anonymised patient data to solve serious unmet medical needs across a wide range of therapeutic areas, enabling a new approach to clinical trial design, drug discovery, development and post-marketing surveillance. Their current products include vital-signs monitoring in hospitals and patient-to-clinician apps to support self-care and remote monitoring of gestational diabetes and chronic diseases such as COPD and heart failure. As the Biological/Clinical lead for the Systems Medicine team you will be responsible for ensuring patient focus for all projects. You will be the central patient and clinical/biological resource for the data-scientists and computational biologists to ensure projects maintain a clinically and biologically relevant focus. This role involves working closely with the data science team across a range of therapeutic areas, ensuring there is a solid biological rationale for the research, along with a clear patient benefit is delivered for each project. In collaboration with the BD team you will translate business and clinical requirements into product/technical requirements. This means building the strategy and operational requirements for the use of clinical data into the drug discovery and development pathway. Responsibilities To be the biological expert to a dynamic team of machine learning and computational biologists to address clinically relevant questions Liaise with clinicians and Trusts to write project plans, outlines, using biological know-how and expertise Work with the data science team to write project reports and determine biological-scientific direction of projects The company also actively encourage the team to publish research results in national and international conferences and scientific journals. REQUIREMENTS PhD in relevant area (i.e. general molecular biology, cell biology, biochemistry or similar) with post-doctoral experience. If you are just finishing up a Post-Doc and looking to move to industry to continue work within the scientific domain, this is the perfect role. Experience working with anonymised patient data, epidemiological longitudinal observational data, or working within the NHS Experience working in a cross-disciplinary teams (Bioinformatics, Biologists, Computational Biologists). An understanding of how machine learning techniques applied to longitudinal data from EHRs can be used for various stages along the drug discovery and development pathway would be highly beneficial Experience in handling and analysing longitudinal discrete and continuous data at the individual patient level. Understanding of how analysis of longitudinal, high dimensional clinical data (either from EHRs or clinical trials) can lead to patient benefit or impact on the drug discovery and development pathway Excellent knowledge of, and practical competence with clinical data ontologies, data models and formats. Working knowledge of drug discovery and development BENEFITS Competitive Salary Company share option scheme 5% employer matched Pension scheme BUPA Health Insurance including Partners and Children cover Free Gym Membership Cycle to work scheme A challenging and fun environment that rewards results

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  • Senior Regulatory Affairs Manager 5/3/2019 12:00:00 AM

    Salary: £0 Location: London

    The client: My client was established in 2012 as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. We offer leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Our aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. They are currently hiring for a Senior Regulatory Affairs Manager who will provide operational management to the regulatory group and support the Head of Regulatory Affairs. This role has a focus on supporting the clinical trial and manufacturing initiatives and as such calls for strong experience in clinical trial submissions and CMC and GMP requirements of product and process development for the EU and US markets. Most candidates will have: - Minimum 5+ years’ proven experience in an appropriate regulatory role - Experience of registration of cell and gene therapies for clinical trials - A good team player with excellent written and verbal communication skills - Proven ability to evaluate and implement efficient regulatory strategies and manage complex regulatory issues including advanced therapies - Graduate in a life science subject as a minimum, post graduate degree desirable - Experience of FDA and EU centralised procedures such as orphan drug, paediatric and licensing applications is highly desirable but not essential - Experience of registration of cell and gene therapies for clinical trials in the US and other markets is extremely desirable but not essential For more information about the role or for a chance to apply, please contact Philip Adebiyi on 0161 250 5049 or Philip.Adebiyi@wearenorthpoint.com and I’ll be happy to help

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  • Interim Senior Clinical Project Manager 4/30/2019 12:00:00 AM

    Salary: £0 Location: London

    The Client: My client is a science driven company in the pharmaceutical sector specialising in cell and gene therapies. Their vision is to drive the growth of the industry by helping cell and gene therapy organisations across the world translate early stage research into commercially viable and investable therapies. Wanting to be the global leader in development, delivery and commercialisation of cell and gene therapy, they have state-of-the-art viral vector laboratories and a £55million GMP manufacturing centre. They are currently hiring for an Interim Senior Clinical Project Manager for a 15 month FTC. The purpose of this role is to ensure the planning, implement and monitoring of the progress of clinical trials and to be responsible for the overall day-day operational management. Preparation and review of protocols, CRFs and informed consent documents as well as other essential documents required to run clinical trials. Managing study budgets, contract negotiations and oversight of clinical vendors. Most candidates will have: - Minimum 4 years clinical project management experience - Educated to degree level within life sciences or equivalent nursing qualification/experience - Experience working in NHS clinical trial structure in UK will be extremely advantageous - Familiarity with UK regulatory environment - Ability to manage multiple and varied tasks - Ability to engage constructively with colleagues at all levels across different departments - 5+ years strong clinical research background For more information about the role or for a chance to apply, please contact Philip Adebiyi on 0161 250 5049 or Philip.Adebiyi@wearenorthpoint.com and I’ll be happy to help

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  • French Speaking CTA 4/17/2019 12:00:00 AM

    Salary: £0 Location: Chelsea

    The Client: Based in Central London, my client is a leading Clinical organisation looking to take on an experienced French Speaking, CTA, working as a key member of the project team. This role will provide in-house operational support to study teams, ensuring standardisation and consistency of tracking across studies in accordance with SOPs. Key Responsibilities: • Day to day operational support to Lead Ops, CPMs, CRAs for defined tasks during study • Collects, co-ordinates and maintains essential documents and the Trial Master File (TMF) • Logistics of investigator and monitor meetings organised including the development of presentation materials under direction of PM • Active membership of projects meetings: meetings booked, minutes taken and communicated • Documents learnings and recommendations from study debriefs and best practice identified and implemented in collaboration with manager and colleagues • Study area managed according to standards including set up, access rights and maintenance of study related documents • Development and maintenance of study specific documents and tracking tools under direction of PM • General filing and adhoc administrative task • Documentation provided to support the preparation of clinical study reports and publications • Health Authority/ IRB submissions and approvals tracked • Awareness of and compliance to all policies and procedures including: Finance, Procurement, IT and Legal Most Candiates will have: Experience work as a CTA or another role with similar capabilities, in a clinical setting. Experince in full project life cycle monitoring Be fluent in French (Reading, Verbal, and Written) Strong organisational skills and the ability to work over multiple projects Salary: Daily rate (discussed at point of application) Contract term: 1 year For more information on this role or for a chance to apply, please contact Philip on Philip.Adebiyi@wearenorthpoint.com or call on 0161 250 5049 and Ill be happy to help

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  • CRA II 3/29/2019 12:00:00 AM

    Salary: £0 Location: Chelsea

    Bi-lingual CRA 1-year rolling Contract (day rate) Based in Central London, my client is a leading Clinical organisation looking to take on an experienced Bi-lingual CRA (European Languages). You will be responsible for performing and coordinating all aspects of clinical monitoring and site management, ensuring that country and site targets are achieved, in compliance with ICH/GCP, company SOPs and all other applicable regulatory requirements. Key Responsibilities: •Oversee all aspects of study site management including; collation of trial related documentation (site contracts, consent documents, letters of agreement, confidentiality agreements), tracking or site performance, status reports to ensure high quality data resulting in consistently low query levels in good Quality Assurance reports. •Assists with execution of site contracts. •Involved in recruitment of potential Investigators, preparation of Ethics Committee/Independent Regulatory Board (EC/IRB) submissions, renewals, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks. •Conduct pre study visits and site initiation meetings; training investigators and other trial staff in the protocol, data collection methods, completeness and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and TRI SOPs. •Track patient recruitment and report on site issues/strategies to increase patient accrual into the trial (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs). •First point of contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing studies. •Oversee tracking of completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion. •Ensure maintenance of project site files including: ethics committee approvals and reports, curricula vitae of investigators and study personnel, training/delegation log clinical documentation is current lab reference ranges are current investigator and site correspondence log schedules of payment. •Conducts remote monitoring and site visits - assessing protocol and regulatory compliance, and reporting conduct using applicable documentation. •Ensure site staff are trained in TRI and protocol specific procedures and are ICH-GCP compliant. •Comply with all applicable laws / regulations of each country in which we do business. •Demonstrate high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians. •Report, write narratives and follow-up on legal, compliance and ethical violations in a timely manner. •Review progress of projects and initiate appropriate actions to achieve target objectives •Input to creation of monitoring plans •Organise and make presentations at Investigator Meetings •Provides support and confer best practice to more junior colleagues and CRAs as necessary. •Create and deliver company specific training and contribute to process development. You will have: •Proven leadership/supervisory experience •Life science or other relevant degree •Excellent organisational skills •Excellent interpersonal skills •Good problem-solving abilities •3-4 years CRA experience which must include pre-study, initiation, routine monitoring and close-out visits) •Experience of working in observational trials •Proven ability to develop and update working practices •Flexible and effective communication and negotiation skills •Ideally a strong understanding of cardio vascular disease and treatment •Ability to monitor sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines Salary: Daily rate (discussed at point of application) Contract term: 1 year Start date: Immediate

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  • Associate Director Biostatistics 11/27/2018 12:00:00 AM

    Salary: £0 Location: Fulham

    I am currently looking for an experienced Biostatistician for an award winning global CRO with a mission to accelerate the development of safe & effective medical therapeutics on a global scale. Due to continued growth and success, my client is now looking to appoint an Associate Director of Biostatistics to take a strategic lead position in their existing biostatistics function. If you have a robust history of working within pharmaceutical clinical trials and are currently considering a new chapter in your professional career, then I’d love to hear from you!

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  • Clinical Audit Specialist 4/24/2018 12:00:00 AM

    Salary: £30000 Location: PORTSMOUTH

    Clinical Audit Specialist - Dorset - £30k + Primary Care + Clinical Data + Great company My client are a specialist clinical company providing high-level data and quality information to the NHS. Due to recent success, they now seek a Clinical Audit & Data Quality Specialist to join their friendly team in Bournemouth, just a few minutes’ walk from the beach and shops. In this role, youll work with Primary Care customers to deliver bespoke products, technical specifications and clinical audits. Youll need experience with: + NHS Primary Care Information Systems + Read code terminology + Advanced Excel

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