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Calderdale and Huddersfield NHS Foundation Trust (CHFT) are committed to equal opportunities and welcome applications from all sections of the community, regardless of any protected characteristics.We are committed to recruiting to our values. LeadingOne Culture of Careunderpins our values by creating an environment, tone and behaviours across all parts of the Trust that are fundamentally rooted in compassionate care.We are open to considering a wide range of flexible working arrangements. There are opportunities to flex the days of the week, hours and times of work and place of work including: part-time, job-share, flexible working hours and the possibility to work from home when appropriate. Please talk to us during the interview process to discuss any flexibility that you may require.We received our Silver Award from the Defence Employer Recognition Scheme which is helping actively promote SaBRE - Supporting Britain's Reservists and Employers. This means that we provided its statement of intent to support all Defence personnel and we welcome application to work for us. Find out more - Why Choose CHFT?Our Future PlansThe Department of Health and Social Care has awarded capital funding to invest in local health services at both Calderdale Royal Hospital and Huddersfield Royal Infirmary. This is a significant investment and an opportunity to enhance services for our populations in Calderdale and Huddersfield and West Yorkshire for generations to come. To find out more, please visit overviewWe are seeking a clinical trials officer (to cover maternity leave) to manage the day to day delivery of Investigational Medicinal Products, work with customers to develop new IMPs, and increase the scope of our clinical trials support services including the development of IMP dossiers and Investigator's Brochures.The ideal candidate will have a science degree, or have completed the Clinical Pharmaceutical Scientist qualification. They will possess an excellent working knowledge of GMP and GCP gained through working on the delivery of clinical trials and the manufacture of IMPs or manufacture of licenced/unlicenced medicinal products. In addition they will be self-starting, highly motivated, and committed to the development of this area of business at HPS.Main duties of the jobThe post holder will be responsible forDelivery of clinical trials projects including preparation of supporting documentation, liaison with customers and production teams. Working with the Regulatory and Clinical Affairs Manager to develop new clinical trials projects and tender submissions. Working for our organisationHuddersfield Pharmacy Specials (HPS) is a NHS hosted Specials manufacturing unit. Our mission is to provide high quality, affordable specials throughout the UK to both Primary and Secondary Care. At HPS we manufacture a wide range of products including dermatological, oral and topical liquids, infusion fluids and ampoules. We also provide a bespoke packaging and labelling service.The facility has a MHRA Manufacturer "Specials" Licence (MS), a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)).Detailed job description and main responsibilitiesMain Tasks will include:Developing Opportunities for the production of IMPs Contribute to the construction of tender responses for clinical trials opportunities. Liaison with production and development teams to validate potential approaches to the manufacture of products for new clinical trials opportunities. Compiling clinical and technical data for Investigator's Brochures and IMP Dossiers for regulatory applications Works with Development Team to schedule developmental activities including analytical work and production development batches. Works with regulatory advisors, study sponsors and the Regulatory and Clinical Affairs Manager to complete required regulatory dossiers including IBs and IMPDs Compiles required data into appropriate document formats, including summaries and reviews. Checks dossier information for clarity and completeness prior to submission. Managing timelines for the manufacture and delivery of IMPs With Head of Production and Section Heads agrees production timelines and schedules production activities. Contributes to the generation of production SOPs and documentation relevant to the production of IMPs including DevBMRs and BMRs. Works with section heads to plan production scheduling to meet the requirements of specific trials taking into account available stability data and shelf lives. Manages the storage and distribution of IMPs including where required temperature controlled environments. Maintains appropriate documentation covering the storage and distribution of IMPs. Maintains project boards and tracks progress against agreed timelines. Maintains project plans and ensures regular updates. Communicating with Sponsors and Investigators associated with Clinical Trials involving IMPs developed and / or manufactured at HPS Communicates project plans, timelines, and status updates to inform Sponsors and Investigators of actions and progress on the development of IMPs and support for clinical trials. Maintaining systems for compliance with regulatory requirements for the conduct of clinical trials and the manufacture of IMPs Maintains and complies with appropriate policies and SOPs to meet regulatory requirements for GMP / GCP compliance and contributes to the development of the quality system. Maintains working knowledge of applicable legislation and applicable good practice i.e., GCP, GMP, GLP, GDP. Attends meetings and conferences relevant to the provision of clinical trials services. Manufacture of clinical trials products Participates in the manufacture of clinical trials products and the validation of systems and equipment used in the manufacture and packaging of clinical trials products. Participates in the Performance Development Review process.Duties and responsibilities of the post. Covers the duties of other staff during periods of sickness and absence and undertakes any other reasonable duties. Handles and moves goods and equipment (maximum weight 25kg), transferring them between cages, trolleys, cupboards, work areas and shelving that are at different levels. Complies with Trust and departmental policies relating to security and patient confidentiality ensuring that procedures are carried out in accordance with safe systems of work and current legislation. Managing Self Participate in regular supervision. Attend all mandatory training. Participate annually identifying, developing, and agreeing your own development plan with your Line Manager using the Trust Appraisal. Comply with all Trust policies, procedures, and protocols. Carry out duties with due regard to the Trust's Equal Opportunity Policy. Seek advice and support from Line Manager whenever necessary. Maintain professional conduct including appearance at all times. Ensure maintenance of Professional Registration. Person specificationQUALIFICATIONS / TRAININGEssential criteria BSc in Chemistry, Pharmaceutical Science or relevant Science or Engineering Degree. Demonstrates commitment to CPD to maintain skills required. Desirable criteria Post graduate qualification in Clinical Trials or other relevant higher education. PRINCE 2 or similar project management qualification Specific GCP training KNOWLEDGE, EXPERIENCE & EXPERTISEEssential criteria Experience of product development and clinical trials. Experience of project management Demonstrates knowledge of GMP and GCP gained through practical experience and / or post qualification training Demonstrates knowledge of pharmaceutical processes and dosage forms. Desirable criteria Knowledge of GLP and GDP Knowledge of drug development processes Toxicology / clinical pharmacology Post-qualification experience in a pharmaceutical or relevant industrial environment. Experience in delivering clinical trials or technical projects. COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)Essential criteria Able to construct functional standard operating procedures and other documentation. Able to manage and prioritise own workload. Project management. Excellent interpersonal and communication skills. Able to remain calm and confident under pressure. Practical ability/manual dexterity. Pays attention to detail. Demonstrates critical thinking. Able to motivate, persuade and inspire staff. Presentation skills. Intermediate level computer skills (word processing, spreadsheets and database use) Our vision is to provideOne Culture of Carefor one another in order that we can provide compassionate care for the people who use our services. We are passionate about creating a workplace where we work together to get results, encouraging colleagues to have their say, in order to co create the change we want to see. We take pride in the diversity of our workforce that's why we encourage applications from all. Reasonable adjustments will be made for disabled applicants.Please ensure your application is submitted with referees who can verify your employment/education history over the last three years and include valid email addresses for them. We will request electronic Factual Employment References from your previous employers. These references will be requested before you are issued with an unconditional offer of employment letter.Candidates who require a Skilled Worker visa to work in the United Kingdom can determine the likelihood of obtaining a Certificate of Sponsorship for this position by assessing their circumstances against the criteria specified on the Check if you need a UK visa - GOV.UK website. We encourage all applicants to review these criteria carefully to understand their eligibility for sponsorship.If you are appointed to a post, information will also be transferred into the NHS Electronic Staff Records system. The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.You may be required to undertake a DBS. The Trust will administer the DBS check on your behalf and will recover the cost (Enhanced £54.40, Standard £26.40 or Basic £26.40) from your salary when you commence in post (including Internal staff). You will also be required to participate in the DBS Update Service and pay the £16 cost per year.This is a condition of your employment.CHFT is part of the West Yorkshire Association of Acute Trusts (WYAAT), a collaborative of the NHS hospital trusts from across West Yorkshire and Harrogate working together to provide the best possible care for our patients.If you have any questions please contact for assistance.Employer certification / accreditation badgesApplicant requirementsThe postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.Documents to downloadJD and Person Spec (PDF, 544.6KB)#J-18808-Ljbffr