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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Tempo Maidenhead, Berkshire, 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 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 Maidenhead , UK, and this position is hybrid (requiring 3 days per week on-site). Preferably the candidate will have experience working in Oncology.

There is a pre-identified candidate for this role, but other applications are welcome.

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:

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.

Qualifications / Requirements:

BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.

A minimum of 3 years of UK clinical trial experience is preferred. Experience of managing Oncology studies would be an advantage

A minimum of 1 year demonstrable Project Management experience is required

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 Tempo office, Maidenhead.

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 organization.

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:

Preferred Skills:

Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics