Senior Clinical Study Administrator - Office-based, Luton, UK - FSP

Parexel is currently seeking a Senior Clinical Study Administrator (SrCSA) to join us in Luton, UK. You will be assigned to one of our key sponsors and the role will operate from their site in the Luton area. 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. 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.

• 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. Supports CRA in the close-out activities for the ISF. Responsible for layout and language control, copying, and distribution of documents. Supports local translation and spell checks in English to/from local language, as required.
• Regulatory And Site Start Up: Assists in the preparation, review, and tracking of documents for the application process. Supports timely submission of proper application/documents to EC/IRB and 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 technical standards such as Submission Ready Standards (SRS).
• Budgeting, Agreements, and Payments: Prepares and supports contract preparation at a site level. Supports HCO/HCP payments in accordance with local regulations.

• High school/secondary school qualifications (or equivalent).
• Proven organizational and administrative skills.
• IT proficiency.
• Fluent in written and spoken English.
• Previous administrative experience, preferably in the medical/life sciences field.
• Knowledge of the clinical study process and ICH-GCP guidelines is preferred.
• Good communication, interpersonal skills, and ability to work in an international team.
• Willingness to train others on study procedures.
• Excellent organization, time management, and attention to detail.
• Ability to multi-task in a high-volume environment.
• Team-oriented, flexible, with high ethical standards.

We care about our people and your passion, as they are key to our success. We offer an open, friendly work environment with opportunities for career development and skill enhancement within Parexel.