Clinical Trial Leader - 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. linical Trial Leaders at Parexel FSP play a pivotal role in supporting, coordinating, and delivering our clients’ regional and global clinical trials. This includes full involvement in study start-up, maintenance, and close-out, as well as vendor management and CRA oversight. If you’re experienced within these activities, we can offer you a stellar future. One that will not only involve you in internationally significant developments for top name sponsors, but also equip you for project management and other senior level roles. Our CTL's each work with one sponsor exclusively, in a truly collaborative partnership. We offer exceptional financial rewards, training, and development. Expect exciting professional challenges, but with a healthy work/life balance. Some specifics about this advertised role 100% home based Work on Phase I, II, or III or IV, regional or global trials. Oncology and Cardiology work available (sponsor dependent) Lead member of a strong study management team (trial dependant) Start-up planning and vendor management responsibilities Play a key role in handling high profile and sensitive operations, taking a study to the next level. Highly respected top 50 Pharma sponsor Not your therapeutic area? Not quite your role? Don’t worry. We’ve other study management opportunities explore current openings, visit https://jobs.parexel.com/functional-service-provider Clinical Trial Leaders at Parexel FSP Due to the nature of our projects and sponsors, we hire more experienced Study Managers, who have already spent several years in the role, with global study experience. You’ll report to a Senior Project Leader but will have considerable operational freedom and plenty of sponsor contact. Study managers who join us often say they particularly like the agility and pace here. We’re all about making the right decisions fast. Our CTL's each work for a single sponsor. You’d typically manage between one and three studies, depending on size and complexity. You could also be part of a team of study managers on a major trial, potentially in the lead role if you’re more experienced. Working with Parexel FSP means you’ll be directed by the sponsor, while remaining part of our worldwide team. We’ll partner with your sponsor to plan your training and career progression. Promotion can come at any time, and not just at the end of an assignment. As we mentioned, the study manager role here is more influential than the norm. Trial start-up, maintenance and close out. Vendor management. Overseeing CRAs and studies. Chairing meetings. Coordinating submissions. All will be within your scope. In fact, as your experience builds, your role will develop naturally towards project management. Equally, study management is a technical career path here in its own right. There are fantastic opportunities to develop your experience and skills. Just finally, we value work-life balance. We aim to keep regular hours and maintain our lives outside the office. We’ll value your welfare just as highly as that of our patients. And our managers will listen to, and act on, any concerns. What we look for in Clinical Trial Leaders Precise requirements for each CTL's role vary from sponsor to sponsor, but generally we look for people with at least 5 years’ direct experience as a global study manager. Additionally, you’ll need: - Past exposure to trial start-up, maintenance, and close activities. Experience of overseeing CRAs, vendors and deliverables globally The ability to work effectively with a wide range of clinical, technical, biometric, and regulatory stakeholders, as well as with sponsors. In depth experience working within international Oncology trials. Demonstrated experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend. Experience of following milestones for the region with the local team. Experience in Phase I-III trials and CRO management. Experience of coordinating the EC submission in participating countries. 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.