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Clinical Trial Manager

Location: High Wycombe
Company: Johnson & Johnson
Johnson & Johnson
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Clinical Trial Manager Multi TA's Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for a Clinical Trial Manager to be located in High Wycombe, UK; Warsaw, Poland; Madrid, Spain; Beerse, Belgium; Leiden, Netherlands. Other EU locations may be considered within reasonable distance to R&D offices and if conducive to business continuity Position Overview Clinical Trial Manager The Clinical Trial Manager ensures 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. As a CTM Multi-TA, you will get to work on a verity of studies, such as: Immunology Cardiovascular and Metabolic Diseases Infectious Diseases Vaccines Neuroscience Pulmonary Hypertension Key Responsibilities Leads the Study Management Team (SMT), drives issue resolutions, and provides updates to all Trial Team members on results. Ensures that (SMT) operates in a constant state of inspection-readiness. Ensures required reports are generated and available for real time status tracking. Contributes to data collection to support the site selection process Establishes enrolment commitments and ensures 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. 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, 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. Ensures 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. Coordinates data cleaning with some supervision towards a timely and successful database lock Participates in Global Clinical Development Initiatives as assigned. Can act as a Subject Matter Specialist Qualifications Qualifications A minimum of a BS degree or equivalent is required Minimum of 3 years clinical operations experience in the pharmaceutical industry, CRO or equivalent Strong project planning/management and effective communication 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 Consistent track record to cultivate team productivity and cohesiveness. Effective leadership skills and ability to manage multiple partners. Able to proactively identify and preempt budget issues and work with key partners to resolve. Detail orientated with strong analytical skills. Experience with management and supervision of CROs/vendors is preferred. Who is Janssen? Were 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, Alzheimers disease to cancer, we are committed to issues that touch everyones lives. Our mission is to transform individual lives and fundamentally change the way diseases are handled, 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. What were about: We are passionate about our work and play vital roles across a range of professional disciplines. We care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers! We share a kind of DNA where were each: Committed to caring Responsible to our communities Ready to apply our knowledge and know-how Unique in our background and experiences The drivers of our own success Passionate about doing whats right Make a unique mark in your career! If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com 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. #GIFTS Primary Location United Kingdom-England-High Wycombe- Organization Janssen Cilag Ltd. (7360) Job Function R&D
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