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• Johnson & Johnson Innovative Medicine

  

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The SU-Lead LTM is responsible for proactively coordinating and leading the global and local trial teams to deliver quality trial documents as required to support the preparation and completion of study submissions in line with UK regulatory & ethical requirements. The SU-Lead LTM proactively leads or contributes to process improvement, training and mentoring of other colleagues as needed. Are you ready to join our team? Then please read further! You Will Be Responsible For • Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions and essential documents collection., • Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorisations for study initiation., • Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence., • Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities., • Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency., • Collaborating with the Global and Local Project Teams during study start-up to deliver for the UK., • Contributing input to the study management documents at a country level or initiating development of these documents for a single country trial, as per SOPs., • Leading and coordinating local start-up team activities in compliance with SOPs, local procedural documents and applicable regulations, • Maintaining and updating trial management systems. Using study tools and management reports available to analyse submission progress, • Monitoring submissions progress and initiating corrective and preventive actions (CAPA) when the trial deviates from plans and communicating study progress and issues to study management teams., • Conducting local team meetings and providing or facilitating training when needed (i.e. implementation of changes in submission related processes). Qualifications/Requirements • A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required., • Minimum of 7 years of UK clinical trial experience is preferred, including site monitoring experience and local EC submission experience., • Should have solid understanding of the drug development process, including GCP, and local ethical & regulatory requirements., • Strong leadership and communication skills., • Project management experience strongly preferred., • Therapeutic area experience in Haematology, Oncology or Immunology preferred., • Proficient in speaking and writing the English language., • Excellent written and oral communication skills Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs., • Demonstrated ability to lead initiative/small teams., • Ability to work on multiple trials in parallel in different disease areas, if required. Benefits We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Required Skills Clinical Site Monitoring, Good Clinical Practice (GCP), Leadership Project Management, Submission Management Preferred Skills Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)

• Hays

  

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  Your new company You will be joining an organisation committed to continuous growth and development. The company values innovation, collaboration, and professional development, ensuring employees have the tools and opportunities to thrive. Based in High Wycombe for 5 days on-site, the team works closely across departments to deliver excellence and foster a culture of learning. Your new role As Learning and Development Manager, you will lead the learning function and implement the group's learning strategy. Your responsibilities include: • Designing and delivering training programs., • Managing the group training platform and monitoring its effectiveness., • Collaborating with managers to identify training needs and support career development., • Overseeing apprenticeship and traineeship programmes., • Managing training budgets and vendor relationships., • Driving succession planning and appraisal processes. What you'll need to succeed • Minimum 3 years' experience in HR or L&D and 1 year in a management role., • Strong knowledge of learning and development methods and familiarity with e-learning platforms., • Experience in project management and budgeting., • Excellent communication, relationship-building, and problem-solving skills., • Ability to work proactively, with attention to detail and strong time management. Desired Skills and Experience Learning and Development strategy design and delivery Training program development and facilitation E-learning platform management Project management Budget management Coaching and mentoring Succession planning Performance appraisal support Stakeholder engagement and relationship building Data analysis and reporting Time management and prioritization Problem-solving and initiative Communication and collaboration Attention to detail Proactive and agile work ethic Hays EA is a trading division of Hays Specialist Recruitment Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be found at hays.co.uk

• Johnson & Johnson Innovative Medicine

  

  Trial Delivery Manager

  1 day ago

  High Wycombe

  At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function R&D Operations Job Sub Function Clinical Trial Project Management Job Category Professional All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description J&J IM - Trial Delivery Managera J&J Flex – 3 days office/2 days remote – International Locations Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Netherlands, Germany, France, Belgium- Requisition Number: R-045529 United Kingdom - Requisition Number: R-047381 United States - Requisition Number: R-047393 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Company Overview Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at ___Position Summary The Lead, Trial Delivery Management (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery. Principal Responsibilities • Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation)., • Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight., • Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries)., • Support development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing., • Provide input into trial level operational strategies., • Resolve trial-related issues and mitigate trial-related risks., • Participate in process improvement activities at a trial, compound & cross-DU level, as needed., • Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues., • Mentor & support onboarding of new team members, particularly those in Trial Management. Education And Experience Requirements Required Minimum Education: BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) Required Years Of Related Experience Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries. Required Knowledge And Experience • Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial., • 2-3 years’ experience supporting multiple aspects of a global clinical trial., • Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness., • Experience leading without authority and in muti-functional matrixed and global environments., • Excellent decision-making, analytical and strong financial management skills are essential to this position., • Operate and execute with limited supervision. Experience mentoring/coaching others., • Strong project planning/management, communication and presentation skills are required. Other Percentage Travelled: Travel up to 15-20% of the time, defined by business needs. Benefits We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Office Location: We are pleased to announce that from mid-2026, our offices in Wokingham and High Wycombe will move into a modern, state-of-the-art Johnson & Johnson office in central Maidenhead, conveniently situated next to the train station. Required Skills Clinical Trial Oversight, Trial Management, Vendor Management Preferred Skills Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)