Lead Local Trial Manager

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.

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

You will be responsible for:

• 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.
• 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.
• Acting as the subject matter expert for assigned protocols. Developing strong therapeutic knowledge.
• 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.
• 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 when the trial deviates from plan. Identifying and resolving issues. Communicating study progress and issues to local and global study management teams.
• Reviewing and approving Monitoring Visit Reports submitted by Site Managers; identifying issues and/or trends across a trial project.
• Preparing IRAS submissions and responsibility for approvals during the trial.

Education & Experience Requirements:

• BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
• A minimum of 7 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 J&J UK 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 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.

#LI-Hybrid

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)