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. Our purpose is to ensure great research improves the lives of people by providing world class TMF solutions.
The Document Specialist is responsible for contributing towards making our clients’ Trial Master Files (TMF) inspection ready. This role will collaborate with key stakeholders, be accountable for their actions and deliver the highest quality outcome for the client.
In this operations role, you will process records accurately, maintain attention to detail, follow verbal and written instructions while working in a team environment.
Responsibilities will include:
With the appropriate training and experience:
- Process documents into eTMF system following guidance, to the required quality and productivity levels, across multiple clients
- Remap documents across TMF structures according to client-specific guidance and Company SOPs
- Quality Review across multiple core clients, to the required quality and productivity levels
- Remediation of TMF to include query analysis and resolution, and ongoing TMF maintenance.
- Archive preparation, to include inventory review and completion, tracking of paper and box handling.
- Identify opportunities for process improvement.
- Coach and mentor small groups of people
- Coordinate allocation of work across a team
- Use inhouse generated MI to facilitate continuous improvement in quality, productivity and other KPI’s
- Perform analysis of Heatmap data and provide expert advice to client on TMF health.
We are looking for individuals with:
The ideal candidate will have experience using MS Office Word and Excel, attention to detail, ability to make decisions independently using flexible approach and a willingness to work collaboratively. It would be advantageous to have experience working with multiple eTMF systems and TMF structures and good document recognition skills.
- Experience working in a Clinical Research Environment
- Advanced skills in MS word, Excel and Outlook
- Good understanding of ICH GCP and EU Directive
- Pro-active, initiative driven
- Excellent attention to detail
- Excellent verbal and written communication skills
- Ability to work independently or prioritize and seek input where necessary
- Ability to travel and work at client premises
- Focused, starter-finisher, flexible approach
- Helpful, outgoing team worker
Why Work for Phlexglobal?
We offer challenging careers, projects, great benefits and a comprehensive and competitive rewards package, including great training and personalized career development opportunities.
Our benefits typically include a competitive base salary and generous annual leave. We also provide 401k, medical, dental and vision insurance and life insurance.
Your career and personal development are 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 personalized learning and development plans, and regular performance reviews to enable you to achieve your career development goals.