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. Key Accountabilities: Assists in coordination and administration of clinical studies from the start-up to execution and closeout Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study. Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents. Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study. Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements. Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”. Ensuresthat all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF. Contributes to the production and maintenance of study documents, ensuring template and version compliance. Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the Authoring Guide for Regulatory Documents. Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities. Sets-up, populates and accurately maintains information in tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems). Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts). Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations. Manages and contributes to coordination and tracking of study materials and equipment. Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs. Leadsthe practical arrangements and contributesto the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes. Prepares, contributes to and distributes presentation material for meetings, newsletters and websites. Responsible for layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required. Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails. Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material. Ensures compliance with Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). Ensures compliance with local, national and regional legislation, as applicable. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Clinical Study Administrator(CTA).

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