Senior Local Trial Manager

Johnson & Johnson Johnson & Johnson · Pharma · High Wycombe, Buckinghamshire, United Kingdom

This role is for a Senior Local Trial Manager at Johnson & Johnson, focusing on the operational management and oversight of clinical trials within the UK. The position requires collaboration with clinical operations, ensuring compliance with SOPs, GCP, and regulatory standards, managing trial timelines and budgets, and acting as a primary country contact for assigned studies. The role also involves process improvement, training, and mentoring junior staff. A degree in Life Sciences or related field, a minimum of 3 years of UK clinical trial experience (preferably Oncology), and 1 year of Project Management experience are required, along with a strong understanding of drug development, GCP, and local regulatory requirements.

What you'd actually do

  1. Collaborating with the Manager, Clinical Operations (MCO) for country protocol and site feasibility assessments. Ensuring consistent and high quality conduct of site qualification visits and country feasibility reports. Recommending suitable sites for selection. Setting predictable and realistic start up timelines.
  2. Leading and coordinating trial activities in compliance with SOPs, other procedural documents and regulations. Leading local project planning activities to meet recruitment targets and to deliver high quality data on time and within budget.
  3. Acting as the subject matter expert for assigned protocols. Developing strong therapeutic knowledge.
  4. Acting as primary country contact for a trial. Establishing and maintaining excellent working relationships with external organisations, in particular investigators, study trial coordinators and other site staff; and internal partners, including Medical Affairs.
  5. Maintaining and updating trial management systems. Using study tools and management reports available to analyse trial progress.

Skills

Required

  • BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
  • 1 year demonstrable Project Management experience
  • proven understanding of the drug development process including GCP and local regulatory requirements
  • Proficient in speaking and writing the English language
  • Excellent written and oral communication skills
  • Strong leadership skills; demonstrated ability to lead initiatives/small teams
  • Ability to work on multiple trials in parallel, if required
  • Flexibility to commute 3 days per week to High Wycombe/Maidenhead office

Nice to have

  • 3 years of UK clinical trial experience
  • Experience of managing Oncology studies

What the JD emphasized

  • UK clinical trial experience
  • Project Management experience
  • GCP
  • local regulatory requirements