Clinical Trial Manager

Contenido de trabajo

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 aim 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. We are looking at a future where the world of healthcare will be challenged by informed 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 multiple Clinical Trial Managers based in either; the UK, Belgium, Spain, The Netherlands, Poland, or the USA(Springhouse/Raritan/Titusville). The CTM will ensure regional/global clinical operations results progress according to agreed upon timelines and achievements as leader of the Study Management Team (SMT). 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. The CTM will support the GTL in leading related CRO country & site activities. Duties/Responsibilities Study Management Team Leader, Leading the SMT, drives issue resolutions, and provides updates to all Trial Team members on the result status. Ensures required reports are generated and available for real time tracking of trial status. Site selection, enrollment, monitor study progress Supporting 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 raising. Financial planning and tracking 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. Ensures availability of required reports to support real time tracking of trial status according to trial plan. Builds 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 critical issue processes, External Service Provider Oversight Plan, Filing and Archiving Plan. Training and Investigator Meeting 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 GCDO. Establish and maintain excellent working relationships with internal partners, 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. Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness. 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. Qualifications perations experience in the pharmaceutical industry or CRO! Previous clinical trial management experience in Pharma and/or CRO. Strong project management skills! Proven track record in successfully managing various aspects of trials from start-up to database lock! Previous experience in coordinating global or regional teams Proven track record to develop team efficiency and cohesiveness. Demonstrated experience in speaking publicly to partners Ability to competently plan and supervise country and select vendor budgeting process. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. 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. Primary Location United Kingdom-England-High Wycombe- Other Locations Europe/Middle East/Africa-Spain-Community of Madrid-Madrid, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, North America-United States-Florida-Titusville, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse Organization Janssen Cilag Ltd. (7360) Job Function R&D Requisition ID 2105958870W