Clinical Trial Operations Specialist

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. The Clinical Trial Operations Specialist (CTOS) is a key member of Clinical Delivery Team accountable for clinical trial execution excellence including any of the following: planning, coordination, and conduct of complex, regulatorily defined tasks; seamless trial operation and communication to all applicable stakeholders; timely delivery of all materials, documentation and information needed to setup, execute and deliver assigned trial (s), and oversight of trial supplies, submissions, and other operational parameters. Key Accountabilities: Clinical Trial Operations Accountable for the planning, coordination, and conduct of trial activities according to ICH-GCP Assures the seamless conduct of trials within defined timelines in close coordination and communication with the Clinical Trial Leader (CTL) Collaborate and interact with other core and extended trial team members, Regional Operating Unit (R/OPUs) level functions (e.g. Clinical Trial Manger) and interface functions (i.e. Clinical Trial Supplies Unit, Sourcing, Legal) Ensures cooperation with external functions (i.e. Clinical Research Organizations, advisors, investigators) to conduct clinical trials Independently manage correspondence, complex reports, tracking tools and budget overviews Address and answer complex questions from global and local trial teams and trial sites; mediate decisions under own responsibility Communication, ordering, and tracking of information rel