Experienced CTA (fluent Japanese)
The opportunity Are you an experienced CTA with expert knowledge of the Trial Master File (TMF) looking for something different? The role We are looking for individuals with hands on experience of every stage of the critical path of a clinical trial to provide logistical support to a number of projects mainly focussing on our Japanese clients. Candidates should have a good understanding of the Trial Master File (TMF), the Investigator Site File (ISF) and essential study documentation. This role can be remote based or Phlexglobal office based. A full job description will be provided ahead of interviews but in brief, your role will include: • Pre audit/inspection review of Client Trial Master File documentation electronically. • Devising new filing structures as well as basic filing maintenance (electronic and hard copy) • Scanning and indexing of client study documentation • Training and mentoring other employees as appropriate • To work with the Readiness Leader on existing Phlexglobal projects and to take the lead in delegated projects where skills and competencies allow We need individuals who are: • Able to work to deadlines in a fast paced environment, prioritising their work and multi-tasking! • Proactive, able to work independently, diligent and self-motivated • Focused and have excellent attention to detail • Experienced with remote based working. The ideal candidate will have: • Excellent Japanese and English language skills • Excellent knowledge of ICH GCP and the EU Directives • Excellent working knowledge of clinical study documentation • eTMF experience. • Advanced skills in Microsoft Office products (e.g. Outlook, Excel, Word, databases) To apply: Please apply quoting vacancy reference number PXGUK531, stating your minimum salary expectations and notice period. We look forward to hearing from you! Why work for Phlexglobal? We offer challenging careers, projects, great benefits and a comprehensive and competitive rewards package, including great training and personalised career development opportunities. Our benefits typically include a competitive base salary, generous annual leave and flexible working arrangements. We also provide pension, private medical insurance and life assurance, as well as access to many other benefits including our exclusive retail and gym membership discounts scheme (subject to eligibility). We constantly review our rewards package to ensure you have the best range of benefits available. Your career and personal development is important to us. We provide you with all the training you need to develop the knowledge and skills to be successful at work. We also provide personalised learning and development plans, access to our training and professional development programmes, and regular performance reviews to enable you to achieve your career development goals. All our benefits are subject to the terms and conditions of your employment. The Company Phlexglobal is a specialist provider of technology-enabled, Trial Master File (TMF & eTMF) document management solutions and other support services to the global clinical research market. We offer a unique combination of clinical trial knowledge, document management skills, regulatory understanding and technical expertise to deliver a range of flexible, targeted solutions to meet business needs.