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.
Job Summary
Lead Local Trial Manager (Lead LTM) responsible for local/UK management and oversight of clinical trials, including oncology studies where possible. The role reports to the Manager, Clinical Operations, and works in a hybrid environment (three days on site in HighWycombe, Buckinghamshire). The Lead LTM acts as the primary country‑level point of contact and oversees the full project life cycle from start‑up through database lock and close‑out.
Responsibilities
* Collaborate with the MCO for country protocol and site feasibility assessments.
* Coordinate site qualification visits and prepare country feasibility reports.
* Recommend suitable sites and set realistic start‑up timelines.
* Lead trial activities in compliance with SOPs, GCP, regulatory standards, and company SOPs.
* Plan local projects to meet recruitment targets and deliver high‑quality data on time and within budget.
* Act as subject‑matter expert and develop strong therapeutic knowledge for assigned protocols.
* Serve as primary country contact for the trial, maintaining excellent working relationships with investigators, site staff, and internal partners.
* Maintain and update trial management systems and use study tools and reports to analyse trial progress.
* Monitor country progress, initiate corrective and preventive actions, and resolve issues.
* Communicate study progress and issues to local and global study management teams.
* Review and approve Monitoring Visit Reports from Site Managers, identifying issues and trends.
* Prepare IRAS submissions and secure approvals during the trial.
Requirements
* BA or BSc in Life Sciences, Nursing, or related scientific field (or equivalent experience).
* Minimum 7years of UK clinical trial experience; oncology experience is an advantage.
* Proven understanding of the drug development process, GCP, and local regulatory requirements.
* Excellent written and oral communication skills in English.
* Strong leadership skills with demonstrated ability to lead initiatives or small teams.
* Ability to manage multiple trials in parallel.
* Flexibility to commute 3 days per week to the J&J UK office.
Required Skills
* Clinical Trial Management
* Mentor Coaching
* Oncology
* On‑Site Monitoring
* Project 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
Benefits
Competitive salary, extensive benefits package, flexible working environment, career development opportunities.
EEO Statement
Johnson & Johnson is an equal opportunity employer. All qualified applicants will be considered for employment without regard to any other characteristic protected by law. Reasonable accommodations are provided for individuals with disabilities.
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