At a Glance
- Tasks: Manage clinical trial documentation and support multiple studies from start to finish.
- Company: Join a pioneering biotech company focused on rare diseases.
- Benefits: Fully remote work, flexible hours, and opportunities for professional growth.
- Other info: Work independently in a dynamic, supportive environment with a focus on innovation.
- Why this job: Make a real difference in patients' lives while advancing your career in clinical research.
- Qualifications: Experience in clinical trial administration and strong organisational skills required.
The predicted salary is between 45000 - 55000 £ per year.
Our client is a specialist rare disease biotechnology company developing innovative therapies for patients with significant unmet medical needs. We are seeking an experienced Senior Clinical Trial Administrator (Senior CTA) to join the Clinical Operations team on a long-term rolling contract. This is a fully remote position, working closely with internal teams, CROs, vendors, monitors, and Investigator sites.
The Senior CTA will provide high-quality administrative and operational support across clinical development programmes and will play an important role throughout the clinical trial lifecycle, from study start-up and site activation through to recruitment, ongoing study management, and close-out. The successful candidate will be highly organised, proactive, detail-oriented, and confident working independently within a remote environment.
Key responsibilities:
- Manage and maintain the Trial Master File (TMF), ensuring documentation is complete, accurate, current, and inspection ready.
- Support multiple clinical studies, ensuring key administrative activities and deliverables are completed on time.
- Coordinate internal and external study meetings, including agendas, minutes, actions, decisions, and follow-up.
- Work closely with CROs, vendors, monitors, and Investigator sites on study-related activities.
- Coordinate and maintain essential clinical trial documentation, including regulatory documents, Investigator Site Files, protocol documentation, and participant-facing materials.
- Coordinate and track shipments of study supplies and clinical trial materials.
- Collect, review, and track Investigator site and regulatory documentation.
- Maintain accurate study information using clinical trial systems, including eTMF and CTMS.
- Act as a key contact for study documentation, clinical supplies, and general trial administration.
- Process and track study invoices and insurance documentation.
- Maintain study trackers and proactively follow up on outstanding actions and deliverables.
- Support inspection readiness and continuous improvement activities.
- Ensure all activities are conducted in accordance with SOPs, ICH GCP, regulatory requirements, and company procedures.
Skills and experience:
- Previous experience within clinical research and clinical trial administration is essential.
- Good understanding of the clinical trial lifecycle, ideally from start-up through to close-out.
- Practical experience maintaining a TMF and essential clinical trial documentation.
- Experience using clinical trial systems such as eTMF and/or CTMS.
- Experience working with CROs, vendors, monitors, and/or Investigator sites.
- Experience within a biotech, pharmaceutical, CRO, or similar clinical research environment.
- Experience in rare disease or specialist therapeutic areas would be advantageous but is not essential.
- Excellent organisational skills and attention to detail, with the ability to manage multiple priorities.
- Able to work independently and take ownership of responsibilities.
- Strong communication and stakeholder management skills.
- Proactive, collaborative, and solutions-focused approach.
- Comfortable working within a fully remote environment and managing workload with minimal supervision.
- Good working knowledge of ICH GCP and relevant clinical trial regulations.
- Strong Microsoft Office skills, particularly Word, Excel, and PowerPoint.
Contract Senior Clinical Trial Administrator employer: APX Life Sciences
Join a dynamic biotech company that values innovation and collaboration, offering you the chance to lead impactful global Phase I clinical trials. With a strong focus on employee growth, you'll benefit from a flexible hybrid working arrangement and a competitive contract rate, all while working in a supportive environment that encourages continuous improvement and excellence in clinical operations. This role not only allows you to influence study strategy but also positions you at the forefront of cutting-edge research in a fast-paced industry.
