Lead Local Trial Manager

Johnson & Johnson; High Wycombe; Hybrid; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Lead Local Trial Manager to oversee clinical trials in the UK. This pivotal role involves managing trial operations, ensuring compliance with regulatory standards, and leading a dedicated team to deliver high-quality data. The ideal candidate will have extensive experience in clinical trials, particularly in Immunology and Rare Diseases, and possess strong leadership and project management skills. Join a forward-thinking organization that prioritizes employee well-being and offers a flexible working environment, career development opportunities, and a commitment to innovation in healthcare.

Benefits

Flexible Working Environment

Career Development Opportunities

Health and Well-being Programs

Qualifications

• 7+ years of UK clinical trial experience with site monitoring.
• Solid understanding of drug development and GCP.

Responsibilities

• Lead local trial team activities to ensure compliance with SOPs.
• Collaborate with Clinical Operations for site feasibility assessments.

Skills

Clinical Trial Management

Leadership

Project Management

Immunology Knowledge

Communication Skills

Education

BA or BS in Life Sciences

Nursing Degree

Tools

Trial Management Systems

Job description

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:

Lead Local Trial Manager

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 Lead Local Trial Manager (Lead 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, and this position is hybrid (preferred). The candidate will have experience in Immunology and Rare Diseases, with strong experience in UK study start-up.

The Lead LTM is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The Lead 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 requirements. The Lead LTM proactively leads or contributes to process improvement; training and mentoring of other LTMs and Site Managers (SM).

Are you ready to join our team? Then please read further!

You will be responsible for:

• Collaborating with Clinical Operations Manager for country protocol and site feasibility assessments, in conjunction with the local study team. Implements any local criteria for site selection. Ensuring consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommending suitable sites for selection to participate in trial.
• Collaborating with the Global and Local Project Teams 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 trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leading local project planning activities to meet recruitment targets and delivering high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Maintaining and updating trial management systems. Using study tools and management reports available to analyse trial progress.
• Monitoring country 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 trial team meetings and providing or facilitating SM training when needed (i.e. implementation of study amendment-and changes in study-related processes).
• Reviewing and approving Monitoring Visit Reports submitted by SM; identifying issues and/or trends across a trial project and escalating deviation issues to the CTM/GTL and FM as needed.

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 regulatory requirements.
• Strong leadership and communication skills.
• Project management experience strongly preferred.
• Therapeutic area experience in Immunology and Rare Diseases 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.

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