Job Description
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 FSP has an exciting opportunity for a Sr. CTM. This candidate is responsible for : Manages all operational aspects for implementation of one or more clinical trials and all activities from study start-up through database lock, ensuring Good Clinical Practices (GCP) and relevant SOPs are met Manages study-related service providers and serves as the primary point of contact for contracted CROs, study staff, and contract labs as appropriate; identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate Study Start Up Participates in CRO selection process, validates clinical scope of work, supports auxiliary service outsourcing, provides input into vendor management plan, reviews quality metrics, and shares lessons learned as required Manages and executes vendor kick off meetings, face-to-face meetings, team training, and trial WebEx as required for trial execution Reviews and oversees the development, review, and operational aspects of site investigator grants and grant payment in accordance with sponsor process requirements Provides operational review and content to the study protocol and coordinates completion of QC review of the protocol Coordinates and manages investigator meetings including development of the agenda, management of slide development and review, coordination of meeting planner activities, and presenting at investigator meeting Coordinates the CROs o