Lead Local Trial Manager (Lead LTM) - Location: High Wycombe, Buckinghamshire, United Kingdom (moving to Maidenhead Oct 2026). Hybrid role: 3 days per week on site in J&J UK office.
Purpose
The Lead LTM is the primary point of contact at a country level for assigned studies, providing operational oversight from start‑up through database lock and closeout, ensuring compliance with SOPs, GCP, and regulatory standards. The role supports process improvement, training and mentoring of Clinical Trial Assistant and Site Manager roles, and actively contributes to quality delivery of trials.
Key Responsibilities
* Collaborate with the Manager, Clinical Operations for protocol and site feasibility assessments, ensuring high‑quality site qualification visits and feasibility reports.
* Lead and coordinate trial activities in compliance with SOPs and regulations, managing local project planning to meet recruitment targets and deliver high‑quality data on time and within budget.
* Act as subject‑matter expert for assigned protocols, developing therapeutic knowledge.
* Serve as primary country contact, building and maintaining relationships with investigators, site staff, and internal partners, including Medical Affairs.
* Maintain and update trial management systems, using study tools and reports to analyze trial progress.
* Monitor country progress, initiating corrective and preventive actions when deviations occur, and resolve issues.
* Review and approve monitoring visit reports submitted by Site Managers, identifying trends across project.
* Prepare IRAS submissions and obtain approvals during the trial.
Education & Experience Requirements
* BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience).
* Minimum 7 years of UK clinical‑trial experience (Oncology study experience preferred).
* Proven understanding of drug development process including GCP and local regulatory requirements.
* Proficient in English, both written and spoken.
* Excellent written and oral communication skills.
* Demonstrated leadership ability to lead initiatives and small teams.
* Capability to manage multiple trials simultaneously.
* Flexibility to commute 3 days per week to 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
* Standard Operating Procedure (SOP)
Benefits
Competitive salary and extensive benefits package. Flexible working environment prioritizing work‑life balance. Career development opportunities.
Equal Opportunity Statement
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.
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