Senior Clinical Scientist - FSP

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. Job Overview The Senior Clinical Scientist (SCS) may lead or support a study or studies, depending on size/complexity. The SCS as lead is accountable for the clinical/scientific execution of the protocol. Key Accountabilities: Oversight/Leadership May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol. As lead, will be responsible as the Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites) Responsible for trial design and endpoint development in collaboration with CD Scientific lead on Clinical Trial Team (CTT) Medical Monitoring Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports Monitors data issues requiring clinical input Monitors central lab reports and other external data for safety a