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Your new company Hays have been exclusively retained by an extremely well-funded biotech driving breakthrough innovations in the space of gene therapy.They have developed an innovative new technology that allows them to deliver gene therapies in a novel way to patients with rare diseases and are currently going into their initial clinical trial to validate its use. Alongside this they have multiple other programmes approaching the clinic and several more in development, giving them a very strong pipeline.The company prides itself on innovation and collaborative work and has a very experienced senior leadership & technical team coupled with a C-suite with a truly impressive track record. They are looking to add a Director / Senior Director of Process and Compliance to help them move the company's Clinical Technologies forward and are offering an excellent package plus significant remote working flexibility and the chance to make a real impact. Your new role This is a permanent position, working closely with the CEO, VP Biometrics and other senior stakeholders to ensure clinical (and potentially other, earlier discovery) technologies remain compliant with regulatory requirements as well as driving innovation within this space, eg through the adoption of new processes/technologies/software, etc.The company is ideally looking for candidates to spend some time in office, but the exact amount is open for discussion dependent on candidate location and other factors. Major responsibilities will include a mix of (but aren't limited to): Establish the implementation roadmap for all clinical technologies that enable clinical trial management and data collection mechanisms Develop, manage and implement processes for clinical technology adoption and management, eg software solutions Drive new technology solutions for site visits, clinical monitoring, risk management and provide clinical operations colleagues with innovative ways to make a broader impact on the lives of the patients in our studies Oversee / manage projects to integrate and implement new technologies within clinical data capture or similar Manage the creation of new - and optimisation of existing - quality management processes Liaise with colleagues, eg within IT, Clinical Operations, Biometrics, QA & Regulatory Affairs, to ensure clinical trial activities are properly integrated / aligned to protocols Manage, implement, and develop solutions in site start-up, study recruitment/conduct, and data capture processes across multiple clinical technology programmes Act as a technical expert and leader within the business Drive best practice within the business What you'll need to succeed As well as strong communication skills for dealing with collaborators, stakeholders and vendors/CROs, you should have: A BSc (or equivalent experience) in a discipline such as computer science, biometrics, statistics, IT, or a life sciences discipline such as chemistry, biochemistry or biology Experience of the clinical drug development environment including experience in clinical software development and application deployment is essential, whether from a QA/CSV standpoint, or the data management/clinical operations side Deep expertise of regulatory requirements and industry standards relevant to clinical research, ensuring compliance throughout all stages of clinical trials Proven ability to design and/or develop technology solutions deployed in clinical trials - such as CTMS or other relevant technologies Familiarity with navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processes Well-versed in the utilisation of common tools and technologies within clinical trials, including TMF, CTMS, DCT, and eSource, EDC, etc The ability to manage multiple concurrent projects and effectively prioritise between competing requirements Experience of rare disease / small cohort trials would be an advantage, but is not necessary for this role. What you'll get in return You'll get the chance to make a significant impact on the company's clinical development and R&D/discovery projects, taking on project leadership for a number of different aspects, driving the adoption of new protocols and processes to make their operations as innovative and effective as possible whilst maintaining compliance with regulatory standards.The company are very flexible on salary bands and package depending on the skills of the person coming in and you will be a key member of a highly experienced team, with direct access to the C-suite leadership. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call me on .If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career, especially as there are a number of other bioinformatics, data science and statistics positions available. Keywords: clinical, data, management, manager, quality, systems, process, compliance, controls, tools, CSV, validation, regulatory, compliance, computer, systems, SDTM, ADAM, CDISC, SAS, Snowflake, QA, audit, 21-CFR Part 11, Director, VP, drug, development, R&D, discovery, IT, pharmaceutical, biotech, operations
Come and join one of the UK's largest independent providers in neuro and mental healthcare. We proudly employ over 4000 people - no matter what your experience, we have jobs for everyone. We are offering a £30,000 welcome bonus for the Medical Director position Active Care Group would like to invite applications for a full-time Consultant in Rehabilitation Medicine post. The post is based at the Frenchay Brain Injury Rehabilitation Centre (FBIRC). The FBIRC is the Level 1 specialist inter-disciplinary neuro-rehabilitation centre serving the South West region. The centre operates within a joint working arrangement between North Bristol NHS Trust and Active Care Group. Applications are invited for a full-time Consultant in Rehabilitation Medicine, with a special interest in Neuro-rehabilitation at North Bristol NHS Trust. This post is based at the Frenchay Brain Injury Rehabilitation Centre (BIRU). The BIRU is the Level 1 and 2 specialist interdisciplinary neuro-rehabilitation centre serving the South West region (29 NHSE commissioned Level 1 beds and 23 CCG commissioned Level 2 beds) The centre is a joint working partnership between North Bristol NHS Trust. The post-holder will complete the medical team of two Consultants in Rehabilitation Medicine and one Consultant Neuropsychiatrist alongside a specialist doctor and junior doctor support. The site is part of the wider Active Care Group Neuro Network (consisting of 25 sites) nationally and collaborates with local NHS services due to a joint working arrangement with North Bristol NHS Trust. We focus on the use of clinical expertise, innovation and technology to meet patient's expectations of rehabilitation goals.. Our team work closely together to ensure that every team member is working towards the same practical, realistic goals and that all therapies are focused on the areas that will enable patients to achieve those clearly defined and agreed goals. Key Responsibilities Clinical Leading the multidisciplinary team that undertakes assessments for admissions to the service within our partner acute hospital Providing outstanding, outcome based rehabilitation care Leading the multidisciplinary team in the care and treatment of our patients, including weekly ward round review Attend family meetings, case review meetings and discharge planning meetings as required Practise evidence-based care through national standards and guidelines Provide supervision to their allocated junior doctor Prepare for and participate in external reviews (CQC, Quality Network reviews); liaison with NHSE and participation in local networks and pathways Management Attendance, and contribution to, the Active Care Group Neuro clinical governance meeting. Participate in service development, through research, innovation and local audit. Continue strong relationships with internal and external stakeholders, particularly our partners in the NHS Supervision and support of the site based junior doctor. Engagement in National Networks Ongoing personal development through CPD and annual appraisal (and adhering to the GMC's"Good Medical Practice" / - Medical Director Role A key member of the site based Senior Management Team (including the Hospital Director and Matron) Co-chairing (with Hospital Director) site based clinical governance - focus on quality assurance; thematic review of incidents, safeguarding, clinical model delivery, supervision and training, as well as a focus on reducing restrictive practices. Pharmacy and Medical Management - in conjunction with Ashton's Pharmacy; reviewing assurance processes around engagement from clinical teams with the pharmacy team Chair the local site based Medical Advisory Committee Develop a CPD programme at site for multi-professionals External facing engagement with CQC, local authority and the Provider Collaborative Medical recruitment, supervision and training and development Management of the out of hours medical on-call rota Knowledge, Skills and Qualifications Full registration with GMC with licence to practice MRCP (Required) CCT in Rehabilitation Medicine (Required) Working within an inpatient rehabilitation setting treating those with neurological or brain injury (Desirable) Evidenced based practice Confidence in engaging internal and external stakeholders Patient centred, outcomes-based care Working Environment Requirement for 37.5 hours a week (full time) Junior doctor support Site based clinical governance and Medical Advisory Committee Meeting Opportunity to develop leadership skills through the existing Group wide committee meetings (e.g. Research and Development and Drugs and Therapeutics Committee) What to look forward to A salary of £190,000 plus £30k Welcome Bonus for the Medical Director position (salary would be £180k £10k for Medical Director responsibilities) Medical indemnity paid by Active Care Group Annual leave of 32 days (plus bank holidays) pro-rata for equivalent service Birthday off Join the Active Learning Hub and benefit from a wide range of e learning and face to face training and development opportunities Active Reward App giving discounts and savings on your weekly shop Free 24 hour confidential Employee Assistance Programme Helpline & App to support with legal, health, wellbeing, relationship and consumer advice A Nest Personal Pension account Access to join a Medicash Health Plan for you and your family to save money on everyday health essentials - like going to the dentist or opticians We recognise outstanding Active Behaviours via the Active Awards programme Enhanced Sick & Maternity Pay benefits Refer a Friend Scheme and earn yourself up to £1000 by recommending someone you know ......and, of course, the support and guidance of our qualified clinical and business leadership teams so that you can really develop your career with Active Care Group