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Senior Local Trial Manager

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Job Description - Senior 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 Support

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 driven Senior Local Trial Manager (Senior LTM) who will be responsible for the local/UK management and oversight of clinical trials (or Medical Affairs data generation activity). The head office location is in High Wycombe, Buckinghamshire, UK (moving to Maidenhead Oct 2026), and this position is hybrid (requiring 3 days per week on-site). Preferably the candidate will have experience working in Haematology Oncology.

Purpose:

The Senior LTM is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocols from start-up through to database lock and closeout activities. The Senior LTM is responsible for proactively coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory standards.

The Senior LTM will actively contribute to process improvement, training and mentoring of Clinical Trial Assistant (CTA) and Site Manager (SM) roles. The Senior LTM may have some site management responsibilities.

You need a flexible mindset and have the ability to work in a constantly evolving environment. You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

You will be responsible for:

  • Collaborate with the Manager, Clinical Operations (MCO) for country protocol and site feasibility assessments. Ensure consistent and high quality conduct of site qualification visits and country feasibility reports. Recommend suitable sites for selection. Set predictable and realistic start up timelines.
  • Lead and coordinate trial activities in compliance with SOPs, other procedural documents and regulations. Lead local project planning activities to meet recruitment targets and to deliver high quality data on time and within budget.
  • Act as the subject matter expert for assigned protocols. Develop strong therapeutic knowledge.
  • Act as primary country contact for a trial. Establish and maintain excellent working relationships with external organisations, in particular investigators, study trial coordinators and other site staff; and internal partners, including Medical Affairs.
  • Maintain and update trial management systems. Use study tools and management reports available to analyse trial progress.
  • Monitor country progress and initiate Corrective and Preventive Actions when the trial deviates from plan. Identify and resolve issues. Communicate study progress and issues to local and global study management teams.
  • Review and approve Monitoring Visit Reports submitted by Site Managers; identify issues and/or trends across a trial project.
  • Prepare IRAS submissions and responsibility for approvals during the trial.

Qualifications / Requirements:

  • BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
  • A minimum of 2 years of UK clinical trial experience is preferred. Experience of managing Oncology studies would be an advantage!
  • Should have 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.

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 within our organization.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

#LI-Hybrid

 

 

Required Skills:

Clinical Trials Operations, Good Clinical Practice (GCP), Project Management Leadership, Regulatory Requirements, Trial Management

 

 

Preferred Skills:

Clinical Trials Monitoring, Mentor Coaching, Oncology Trials, Risk Based Monitoring
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