Start-Up Lead Local Trial Manager

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 https://www.jnj.com

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

About Innovative Medicine

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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Start-Up Lead Local Trial Manager (SU-Lead LTM) who will be responsible for the management and oversight of start-up activities for clinical trials in the UK. The head office location is in High Wycombe, Buckinghamshire, UK, with a future move planned to Maidenhead in 2026. This position is hybrid based. Preferably the candidate will have experience across a number of therapeutic areas including Haematology, Oncology & Immunology and expert knowledge of the ethical and regulatory requirements for study start up in the UK.

The SU-Lead LTM will be the primary point of contact at a country level for start-up activities for assigned studies. 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)