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- Tasks: Manage clinical trial documentation and ensure compliance with industry standards.
- Company: Join a leading International Contract Research Organization at the forefront of clinical research.
- Benefits: Flexible home-based work options and opportunities for professional growth.
- Other info: Dynamic team environment with a focus on collaboration and continuous learning.
- Why this job: Be part of innovative projects that shape the future of clinical trials.
- Qualifications: Experience in clinical trials and proficiency in MS Office required.
The predicted salary is between 30000 - 40000 £ per year.
The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Czech Republic, Romania, and India. The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.
We are currently looking for an enthusiastic and talented Document Specialist. This role can be home-based in Romania, the UK, Spain, and Portugal.
TMF Operations Responsibilities- Responsibilities with regards to planning, processes, systems, and training to ensure corporate and compliance needs are met, as well as actively participating in or leading the resolution of any related matters.
- Accountable for the management of assigned TMF Operations tasks, including Trial Master File documentation.
- Adhere to processes and procedures as documented in relevant Standard Operating Procedures (Aixial or Sponsor) and related documents.
- Deliver eTMF services to contractual and compliance expectations.
- Deliver electronic documents to Sponsor where Aixial is not holding/accessing a TMF.
- Follow Aixial/Sponsor SOPs.
- Liaise directly with clients as required.
- Maintain the assigned eTMFs in an audit-ready state.
- Administers eTMF user training and access.
- Perform accurate and timely filing and QC of clinical trial documentation; maintains TMF for conduct period of a project.
- Conduct periodic quality reviews of TMFs, report findings and confirms closure.
- Respond to requests regarding clinical trial documentation and TMF systems.
- Prepare TMFs for archival to the Sponsor.
- Work independently on assigned projects, e.g. specific Trial Master Files or associated tasks.
- Knowledge of TMF Plans, applicable SOPs and systems.
- Workload management and accountability to deliver all scheduled tasks within agreed timelines and budget.
- Act as point of contact for wider departments, to provide status reporting and problem solving.
- Assess accuracy and timeliness of associated work, and implement solutions.
- Participate in system validation and management.
- Provide training, mentoring, coaching for assigned TMFs.
- Supports setup and user administration of other management systems, e.g. DocuSign, Clinical Database Platforms.
- Provide training, mentoring, coaching and/or other support to colleagues, as required.
- Follow ICH-GCP, CFR Part 11, appropriate regulations and company SOPs.
- Timely and accurate entry of relevant study information in the time recording system.
- Proficient in MS Office (particularly MS Word and MS Excel).
- Technically-oriented with ability to learn various associated systems.
- Experience working in the clinical trial industry.
- Experience within TMF Operations in clinical trial industry.
- Experience with Veeva Vault and eTMF.
- A science or health related university degree would be highly advantageous.
- Experience working in a document management environment (e.g. archive, library).
- Planning and Organisational Skills.
- Very good attention to detail, and care and concentration in the accurate handling of important documentation.
- Excellent organisational skills.
- Ability to work calmly under pressure, respond positively to change, and prioritise workload.
- An investigative and meticulous approach to all activities and tasks.
- Communication and Teamwork.
- Professional, positive and enthusiastic attitude, with good interpersonal and communication skills.
- The ability to work effectively and efficiently with internal partners within Aixial.
- The ability to fulfil client expectations and satisfaction within compliance and contractual requirements.
- Adaptable to work under different processes and systems, based on client needs.
- Eagerness to learn and develop new skills.
- Fluent in spoken and written English.
Document Specialist - ROMANIA/UK/EU in London employer: Aixial Group
Contact Detail:
Aixial Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Document Specialist - ROMANIA/UK/EU in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Aixial or similar companies. A friendly chat can sometimes lead to job opportunities that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Knowing about their work in clinical trials and technologies will show you're genuinely interested and ready to contribute.
✨Tip Number 3
Practice your answers to common interview questions, but keep it natural. We want you to sound confident and authentic, so don’t just memorise – understand what you want to convey.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re keen on joining our team at Aixial and ready to dive into the exciting world of clinical research.
We think you need these skills to ace Document Specialist - ROMANIA/UK/EU in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Document Specialist role. Highlight your experience in TMF Operations and any relevant skills that match the job description. We want to see how you fit into our world!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're excited about this role and how your background makes you a perfect fit. Keep it engaging and personal, just like we do at StudySmarter.
Showcase Your Attention to Detail: Since this role involves handling important documentation, make sure to demonstrate your attention to detail in your application. A well-formatted CV and error-free writing will show us you mean business!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Aixial Group
✨Know Your TMF Inside Out
Make sure you understand the Trial Master File (TMF) operations thoroughly. Familiarise yourself with the relevant Standard Operating Procedures (SOPs) and be ready to discuss how you've managed TMFs in previous roles. This will show your potential employer that you're not just familiar with the terminology, but that you can apply it practically.
✨Showcase Your Attention to Detail
Since this role requires a meticulous approach to documentation, prepare examples from your past experiences where your attention to detail made a significant impact. Whether it was catching an error in a document or ensuring compliance with regulations, these anecdotes will highlight your suitability for the position.
✨Demonstrate Your Technical Skills
Be ready to discuss your proficiency in MS Office, especially Word and Excel, as well as any experience with eTMF systems like Veeva Vault. If you have worked with document management systems before, share specific instances where you successfully navigated these tools to enhance efficiency.
✨Prepare for Scenario-Based Questions
Expect questions that assess how you would handle specific situations related to TMF operations. Think about challenges you've faced in the clinical trial industry and how you resolved them. This will not only demonstrate your problem-solving skills but also your ability to work under pressure and adapt to changing circumstances.