Are you ready to turn meticulous study coordination into real-world impact for patients? Do you thrive on bringing order to complexity and keeping multi-site studies inspection-ready? As a Clinical Study Administrator, you will be a core member of a Local Study Team, enabling interventional studies to start well, run to plan and close on time. Your precision with documentation, systems and submissions will help move promising therapies through clinical development with speed and quality. You will collaborate closely with Clinical Research Associates, investigators, vendors and internal experts to keep every site aligned, every document compliant and every milestone visible. You will connect the dots across ethics/regulatory submissions, eTMF/ISF maintenance, CTMS tracking, meeting operations and payments-ensuring a smooth delivery engine for studies that aim to change the standard of care. Depending on experience, you may take on senior-level responsibilities, shaping ways of working and mentoring colleagues as we raise the bar on quality and efficiency.
Responsibilities
* Study Start-up Coordination: Drive the setup of local study activities from feasibility to site initiation, ensuring timelines are realistic, dependencies are clear and start-up risks are mitigated.
* Regulatory and Ethics Submission Support: Collect, prepare, review and track submission packages; partner with Study Start-up teams to deliver timely, high-quality applications to EC/IRB and, where applicable, regulatory authorities.
* Document and File Management: Own the local eTMF and ISF setup and ongoing maintenance, applying ICH GCP and local requirements to ensure continuous inspection readiness through accurate tracking and version control.
* Stakeholder Interface: Act as the primary local administrative contact, working closely with CRAs, investigators, vendors and the LSAD to enable rapid document flow and timely issue resolution.
* Study Conduct Operations: Produce and maintain study documentation using approved templates; manage clinical-regulatory documents in global systems to support efficient publishing and regulatory delivery.
* Systems and Data Integrity: Set up, populate and maintain CTMS and communication tools; support team adoption to improve data quality, visibility of study status and decision-making.
* Contracts and Payments: Prepare and support site-level contracts (where applicable) and coordinate compliant payments to Health Care Organisations and Health Care Professionals in line with local regulations.
* - Materials and Logistics: Coordinate and track study materials and equipment, ensuring sites receive what they need, when they need it, to avoid disruption to patient visits and data collection.
* Meeting Operations and Communications: Lead logistics and contribute to content for study team meetings, monitors meetings and investigator meetings; prepare and distribute agendas, minutes, newsletters and web content with clear, concise language.
* Translation and Distribution: Perform layout, language and quality checks; manage printing, distribution and archiving of study and country-related emails and documents.
* Cross-Functional Collaboration: Interface with Data Management Centres and Global Clinical Solutions to deliver study-related documents and materials that meet submission-ready standards.
* Compliance and Inspection Readiness: Coordinate administrative activities during audits and inspections; uphold company policies, SOPs, Code of Ethics and Safety, Health and Environment requirements, as well as all applicable laws.
* Country-Specific Support: Undertake additional tasks aligned to local organisational needs, scaling your contribution from immediate study deliverables to broader process improvements.
Education and Experience
* High school/Secondary school qualifications aligned to the knowledge and skills of the role.
* Relevant knowledge and ability to fulfil key responsibilities, including but not limited to: Drug development process, International guidelines ICH‑GCP, relevant country regulations.
* Demonstrated in country (UK) proficiency in Clinical Trial Administration.
Role‑Required Skills
* Personal Effectiveness & Drives Self‑Accountability
* Learning Agility
* Financial, Technology & Process Competency
* Active Listening, Fluency in written & spoken business‑level English
* Act with Integrity & high ethical standards
* Effectively work as part of a team, in person and virtual settings, demonstrates cultural awareness
* Identify and champion more efficient delivery of quality clinical trials with optimised cost and time
* Communication & Teamwork - Collaboration, Business Partnering, Impactful Site conversations
* Effective, risk‑based thinking – Plans & Aligns, Problem Solving, Critical Thinking, Decision Making
* Clinical Study Operations (GCP) & Quality Management – Good Documentation Practice (GDP).
* Prior experience in clinical research within a sponsor, CRO or investigator site environment.
* Hands‑on proficiency with eTMF, ISF, CTMS and global regulatory document management systems.
* Experience coordinating contracts and compliant payments for HCOs/HCPs.
* Diploma or degree in life sciences or a related field.
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