Clinical Trial Manager

Janssen R&D - Clinical Trial Manager * Primary Location: High Wycombe-UK * Secondary locations: Spring House, Raritan, Titusville, Cherry Hill - USA, Beerse-Belgium, Leiden/Breda - The Netherlands, Allschwil-Switzerland, Warsaw-Poland, Beijing/Zhengdu-China, Selangor-Malaysia, Taipei-Taiwan, other APAC countries The Company Who is Janssen? We're more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer's disease to cancer, we are committed to issues that touch everyone's lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We seek not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health. The Opportunities We are looking at a future where the world of healthcare will be challenged by advised and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That's why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them. We are recruiting for a number of Clinical Trial Managers (CTM) based in: * Spring House/Raritan/Titusville/Cherry Hill - USA * Beerse - Belgium * High Wycombe - UK * Leiden/Breda - The Netherlands * Allschwil - Switzerland * Warsaw - Poland * Beijing/Zhengdu - China * Selangor - Malaysia * Taipei - Taiwan * other APAC countries As leader of the Study Management Team (SMT), you will ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL (Global Trial Lead). The CTM will support the GTL in leading related CRO country & site activities. Duties/Responsibilities * Leads the SMT, drives issue resolutions, and provides updates to all trial team members on the deliverable status. * Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness. * Ensures required reports are generated and available for real time status tracking. * Contribute to data collection to support the site selection process * Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level. * Ensures the availability of robust recruitment/contingency plans are in place for each region * Ensures timely and accurate documentation and communication of study progress and issue escalation. * Set-up country budgets and supervise actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend. * Supports team by supervising budgets and expenditures as expected by planned trial budget. * Creates and updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents. * Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan. * Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed. * Responsible for the set-up and coordination of Investigator Meetings. * Act as the primary contact person for the local teams within Global Development. * Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies' unit. * Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge. * Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits. * Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools. * Coordinate data cleaning with some supervision towards a timely and successful database lock * Participate in Global Clinical Development Initiatives as assigned. Can act as a Subject Matter Specialist. * Travel up to 20% Qualifications Required Qualifications * Required Minimum Education: BS degree or equivalent required, preferably in Life Sciences. * Minimum of 4 years clinical o