Senior Clinical Study Administrator - Hybrid (Remote/Office-based), Luton, UK - FSP
Parexel is seeking a Senior Clinical Study Administrator (Sr CSA) for a hybrid remote/office-based role in Luton, UK. The role will be based 3 days a week at the Luton site and will support our key sponsors in delivering high-quality clinical studies.
Responsibilities
* Assist in coordination and administration of clinical studies from start‑up through close‑out.
* Serve as the local administrative main contact; work closely with CRAs and trial managers.
* Set up, populate and maintain study data in Client Tracking Systems (CTMS) such as VCV and SharePoint.
* Manage study material and equipment coordination and track supplies.
* Coordinate administrative tasks during the study process, audits and regulatory inspections according to company policies and SOPs.
* Support preparation of internal and external meetings and liaise with participants, vendors, and suppliers.
* Prepare and distribute presentation material for meetings, newsletters and websites.
* Interface with investigators and external service providers to ensure timely collection and upload of study documents.
* Maintain the local electronic Trial Master File (eTMF) and Investigator Site File (ISF), ensuring compliance with ICH‑GCP and local requirements.
* Assist in submission of regulatory documents to EC/IRB and regulatory authorities; prepare documents for electronic submission systems such as ANGEL.
* Prepare contract documentation at the site level, and support Health Care Organization (HCO) payments in accordance with local regulations.
Qualifications
* High school or secondary school qualifications (or equivalent).
* Proven organisational and administrative skills.
* IT proficiency.
* Fluent in written and spoken English.
* Previous administrative experience in the medical or life science field.
* Good knowledge of the clinical study process and understanding of ICH‑GCP guidelines.
* Excellent verbal and written communication and interpersonal skills.
* Ability to train others on study administration procedures.
* Strong organization, time‑management, multi‑tasking, and attention to detail.
* Team oriented, flexible, and responsive to changing priorities.
* Integrity and high ethical standards.
About Parexel
Parexel supports clinical studies across the full range of therapeutic areas and partners with top biotechs and pharma companies. Join us for a supportive, flexible environment that values your career development and offers opportunities for growth.
Sign up today: https://jobs.parexel.com/functional-service-provider
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