Clinical Trial Leader - Phase I Oncology - FSP - Remote

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel are currently recruiting for an experienced global trial manager/project manager, who has experience within Phase I Oncology trials. In this position you will be an invaluable and key member of the clinical delivery team, you are accountable for the set-up, execution and delivery of your assigned trials and contribute to delivery of the sponsors pipeline through accurate planning and efficient execution of trials that bring speed and value to participating subjects and sites. Some specifics about this advertised role Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports development of trial level documents owned by other functions. Verifies and provides input into the country allocation and oversees trial feasibility. Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation. Leads development of core trial and patient facing documents. Integrates patient site level feedback during document development and ensures trials are designed with a focus on patient value. Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting. Prepare and implement amendments of core documents, including training material updates/retraining as needed. In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports trial medical writer in providing the CTR. Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors. Support results/documents disclosure of global registries. Who are Parexel Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients. You’ll be an influential member of the wider team. What we are looking for in the this role For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart. Here are a few requirements specific to this advertised role. Strong clinical trial project management experience. In depth understanding of project management with an emphasis on team work, to promote high performance teams. Experience within early phase oncology studies. Extensive experience in clinical trial project management across international trials. Masters Degree ideal but not essential. Not quite the role for you? Join Our Talent Community and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events. Sign up today https://jobs.parexel.com/functional-service-provider Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.