Senior Clinical Study Administrator - Luton, UK (Hybrid) - FSP

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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 is currently seeking a Senior Clinical Study Administrator (SrCSA) to join us in in the UK. You will be assigned to one of our key sponsors in the region. Working as a SrCSA at Parexel FSP offers tremendous prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, but with time for your outside life. The SrCSA assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. Please note that this role will require attendance at least 3 days/week at the sponsor's office in Luton. Some specifics about this advertised role Trial and Site Administration: Assists in coordination and administration of clinical studies from the start-up to execution and closeout. Serves as local administrative main contact and works closely with the CRAs and/or the trial managers for the duration of the study. Sets-up, populates and accurately maintains information in Client tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc.) and supports others in the usage of these systems. 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. Leads the practical arrangements and contributes to the preparation of internal and external 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. Document Management: Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents. Operational responsibility for the correct set-up and maintenance of the local electronic Trial Master File (eTMF) and Investigator Site File (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. Ensures that 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. 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. Regulatory and Site Start Up: 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. Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the Client 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. Budgeting, Agreements and Payments: Prepares and/or supports contract preparation at a site level. Prepares/supports/performs Health Care Organizations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations. Here are a few requirements specific to this advertised role. Degree (or equivalent), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. Proven organisational and administrative skills. IT proficiency. Proficient in written and spoken English language and fluent in French. Previous administrative experience preferably in the medical/ life science field. Preferably a good working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH-GCP guidelines. Good verbal and written communi

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