Clinical Trials

  • 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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  • Senior Quality Assurance Manager/ Director (GCP) 3/14/2019 12:00:00 AM

    Salary: £0 Location: Nottingham

    Senior Quality Assurance Manager/ Director - Nottinghamshire- Clinical Based in Nottinghamshire, my client is a market leader in biotechnology and clinical manufacturing. Due to continued growth they are looking for a Senior Quality Assurance Manager/ Director. Senior Quality Assurance Manager/ Director , will be responsible for providing leadership and functional management of the GCP Quality Team, implementing, maintaining, and continuously improving Good Clinical Practice (GCP) compliance programs and the Quality Management Systems (QMS) to support the clinical trial activities. The right candidate will have: A proven track record of managing quality systems within clinical research or the pharmaceutical industry. You will have a thorough knowledge of the regulatory framework in relation to the administration of investigational medicinal products and be comfortable managing change and implementing systems and procedures across the organisation. Responsibilities + Previous experience leading a Quality Assurance team in a CRO: Phase 1 or Phase 2 experience is desirable for this role as well as. + Experience and knowledge of GXP Processes and standards. + Thorough knowledge of Quality Systems in relation to Pharmaceutical, Clinical & Healthcare Industries. + Extensive experience of managing change and implementing systems and procedures across the company. + Leading the Quality Assurance and Internal Monitoring teams with respect to functional line management responsibilities and ensuring GCP Quality representational cover to meet the required workload commitments. + Assisting with planning, conducting, reporting and following up of GCP audits (internal and sub-contractor or supplier). + Serving as audit host for client audits and regulatory inspections. You must have: BSc or higher in a pharmaceutical, clinical or life sciences background Minimum of 2 years management experience. (people management) Experience of managing CAPA and QMS systems Experience of working in GCP/ Clinical trials Competitive salary State of the art facilities Excellent training and development opportunities Fantastic benefits

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  • Clinical AI - Clinical / Biological Lead 3/14/2019 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. Their 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. 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. 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 Lead analyses of patient-level data, using machine learning techniques, for identification and characterisation of patient subgroups defined by clinical features and/or disease trajectories. Work with the data science team to bring expertise in state-of-the-art clinical data ontologies and data formats Publish research results in national and international conferences and scientific journals. REQUIREMENTS MBBS or PhD in health informatics, applied statistics or general molecular biology with experience to bioinformatics/machine learning 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 ML 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 longitudinall, high dimensional clinical data (either from EHRs or clinical trials) can lead to patient benefit or impact on the drug discovery and development pathway You are comfortable working in a fast-paced environment and cross-functional teams Excellent communicator, both verbal and written, with ability to influence at all levels and in across departments. Excellent knowledge of, and practical competence with clinical data ontologies, data models and formats. Working knowledge of drug discovery and development Previous experience working with clinical data, within an academic or commercial setting is an asset. 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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  • Head of Clinical Development 2/21/2019 12:00:00 AM

    Salary: £0 Location: London

    My client is global biotech company that’s bridging the gap between scientific research and full-scale commercialisation. Due to internal restructuring, they are looking for a new Head of Clinical Development to join their innovative and dynamic team. The Head of Clinical Development will take full responsibility for all aspects of clinical development including the day to day management of the Clinical Development department. Main Duties and Responsibilities This role has essentially 2 elements: 1. Development focused role: Assessing the suitability of clinical plans both internally and of collaborators 2. Operational focused role: Managing all clinical studies sponsored by the company and for those clinical trial activities where the company has delegated responsibility. What you will need • Educated to a higher Degree level in a life sciences subject, Medical degree or equivalent experience • A minimum of ten years’ experience as a senior manager in either: biotech, biopharma, CMO, CRO, clinical trials, supply chain or the NHS sector with experience in interdisciplinary teamwork, ideally including 2-4 years in a clinical project management role and a minimum of 2 years line management • Preferably experience working with or in the NHS clinical trial structure in the UK • Advantage if experienced working with novel therapies where novel approaches and flexibility may be needed to accommodate new data as trials progress • Excellent interpersonal skills, verbal and written communication skills aligned with the ability to build and maintain strong relationships with peers, senior managers and project team members What you will get • State-of-the-art laboratories • Great Benefits Package This a great opportunity to be part of a dynamic company that’s ensuring that life-changing therapies can be developed for use in health services throughout the world. Get in touch today to ensure that you don’t miss out!

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  • Clinical Pharmacokineticist 1/21/2019 12:00:00 AM

    Salary: £55000 Location: Nottingham

    Clinical Pharmacokineticists- up to £55k Based in Nottinghamshire, my client is a market leader in biotechnology and clinical manufacturing. Due to continued growth they are looking for Clinical Pharmacokineticists from Junior to Senior experience, to join their data sciences team. Working in state-of-the-art facilities, you will be involved in early phase clinical research (both healthy volunteer and patient), playing a key role in the expansion and continuous development of their PK services. In particular PK face challenges due to their complexity (often with multiple study parts), interim modelling, interpretation, protocol changes and the urgent requirements from sponsors for their key results. As such this role will require you to show flexibility and creativity in your PK skills. You will have: A BSc, equivalent or higher in Pharmacokinetics or a life sciences subject (e.g. Pharmacology, Biochemistry, Pharmaceutical Chemistry etc.) 1-3 years of DMPK/ Pharmacokinetics experience Knowledge of ICH GCP and clinical trials Competitive salary (up to £55k – depending on experience) State of the art facilities Fantastic development opportunities Home working available All applicants must have the right to work in the UK.

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  • Senior Clinical Project Manager 1/3/2019 12:00:00 AM

    Salary: £68000 Location: London

    Senior Clinical Project Manager - Bio Tech- up to £68k Based in Central London, my client is a global leader in the Biotechnology sector. Due to continued growth they are now looking a for an experienced Senior Clinical Project Manager You will be responsible for ensuring the planning, budgeting, implementation and monitoring of all clinical trials, including the day to day day-day operational management. This role will require strong knowledge of clinical trials, GCP processes, as well as project management and management skills. You will have: • BSc or equivalent in Nursing, Life Sciences (biological science, pharmacy) or another health related discipline. •Minimum 4 years of clinical project management experience, with at least 2 years of EU multi-national trials experience, or appropriate applicable experience • 7+ years strong clinical research background, including clinical monitoring with medical and/or scientific experience preferred • Experience working with or in the NHS clinical trial structure in the UK would be advantageous • Experience of working within a small and/or start-up organisation would be advantageous • Experience of working with novel therapies or novel approaches in study conduct and flexibility would be advantageous • Familiar with the UK regulatory environment and NHS operational requirements • Familiar with the detail of GCP regulation • Experienced in managing a varied and complex workload Salary up to £68,000 (depending on experience) Fantastic opportunities Great benefits

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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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  • Director, Clinical Business Development – Europe 6/26/2018 12:00:00 AM

    Salary: £90000 Location: Shepherds bush

    My client is an expert within the medical imaging, research and development sector. Due to a fantastic period of growth, a brand new and exciting opportunity for an experience Director of Clinical Business Development (Europe) has been created. They are looking for a self-motivated, driven and enthusiastic individual, with a passion for travel and a strong commercial awareness. This role can be field based or based in their London offices. This role will Focus on customer acquisition by locating, developing, defining, negotiating, and closing business in late-phase clinical trial services. You will be responsible for will targeting, identifying, and qualifying new business opportunities with current and potential clients with a view to growing their European base. You will have: BSc in a Life Sciences or another relevant subject with proficient sales experience. Scientific background and training At least 5+ years of B2B sales experience, preferably in clinical research services market Ability to work accurately under stress and pressure to meet competing deadlines. Ability to travel overnight 25-50% for customer contact; medical conferences, trade shows, etc. with the ability to travel to the various company officers nationally and internationally, as required. Competitive Salary Commission structure (to be discussed by company if progressed) Bonus, Contributory Pension, Private Medical Insurance, Life Assurance & Flexible Benefits options

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  • Project Manager 5/14/2018 12:00:00 AM

    Salary: £34000 Location: YORK

    Clinical Project Manager- Yorkshire- permanent- £34k My client is one of the market leader’s in medical diagnostic and global clinical trial testing services. Due to continued expansion, they are looking for two Project Managers to join their Project Management service team. You will be responsible for agreeing assay and study pricing, acting as the liaison between the company and the client on all assigned studies (including documentation and monitoring study protocols) and ensuring processes are carried out to required standards You will have BSc or equivalent in a life sciences or relevant subject Experience of working to GLP/ GCP standards Experience of working with in clinical trials or life science studies Excellent salary up to £34,000 dependant on experience Great benefits Fantastic career development opportunities As my client are a global company there may be some international travel as required.

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