Job Description

Local Trial Manager

At Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and sophisticated diseases of our time.

Johnson & Johnson Innovative Medicine, Research & Development, discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

We are seeking a Local Trial Manager (LTM) to report to the Clinical Research Manager (CRM), running assigned clinical trials in the UK. You will have operational oversight of assigned protocols from start-up through to database lock. Responsibility for coordinating and leading the local trial team to deliver quality data and trial documents that are aligned with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory standards.

The LTM will actively contribute to process improvement; training and mentoring of Clinical Trial Assistants (CTA) and Site Managers (SM) roles. The LTM may have some site management responsibilities.

Principal Responsibilities: * Collaborate with the CRM for country protocol feasibility (if applicable) and site feasibility assessment. Implement any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommend suitable sites for selection participating in trials. Set predictable and realistic start up time lines.

• 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. Including: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Acting as the Assigned Protocols subject matter expert. Develop strong therapeutic knowledge to support roles and responsibilities.
• Acting as primary country contact for a trial. Establishes and maintains excellent working relationships with external organisations, in particular investigators, study trial coordinators and other site staff; and internal partners, including Medical Affairs.
• Ensuring that the safety of trial patients is at the forefront. Ensure Adverse Events /Serious Adverse Events /Product Quality Complaints are handled within the required reporting timelines and detailed as appropriate.
• Supervising country progress and initiate Corrective and Preventive Action when the trial deviates from plans. Identify and resolve issues.
• We may ask you to assist in negotiation of trial site contracts and budgets. Forecasts and handles local trial budget to ensure accurate finance reporting and trial delivered within budget. Adheres to finance reporting results and timelines.
• Encouraging and empowering trial teams to deliver on the trial commitments.
• Review and approve Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project.
• Keep patient engagement central to all activities. Preparing c ountry specific informed consent in accordance with PD\'s and templates.
• Prepare IRAS submissions and responsibility for approvals during the trial.
• Ensure that studies are Inspection ready .Works with SM to ensure CAPA is implemented for audits and inspections or any quality related visits.
• Conducts accompanied site visits with SM as delegated.
• Contribute and encourage process improvement at every opportunity.

Qualifications

Do you have the following Education and Experience we require?:

• A minimum of a BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
• Experience in clinical trial and site monitoring. Experience of monitoring Haematology-Oncology would be an advantage
• A minimum of 1 year of full project management experience on at least 1 protocol.
• Possess a deep understanding of the drug development process.
• Ability to travel with occasional overnight stay away from home.
• Proven leadership, communication and digital literacy.
• An experienced mentor/coach who can provide training to other LTMs, SMs and CTAs preferred. The ability to lead initiatives/small teams.
• We are looking for a Flexible approach and ability to work in a constantly evolving environment.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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

Johnson & Johnson