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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).
- 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.
- 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 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
✨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.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Show us you know what we do and how you can contribute. Tailor your answers to highlight your experience in TMF Operations and clinical trials.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or family. This will help you feel more confident and articulate when discussing your skills and experiences related to document management.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us you’re genuinely interested in joining our team at Aixial.
We think you need these skills to ace Document Specialist - ROMANIA/UK/EU
Some tips for your application 🫡
Tailor Your CV: Make sure to customise your CV for 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. Let us know what makes you tick and why you want to join our team.
Showcase Your Attention to Detail: Since this role involves handling important documentation, it's crucial to demonstrate your attention to detail. Make sure your application is free from typos and errors. We appreciate precision!
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’re considered for the role. Plus, it’s super easy!
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 Technical Skills
Since the role requires proficiency in MS Office and familiarity with systems like Veeva Vault, be prepared to demonstrate your technical skills. Bring examples of how you've used these tools effectively in past projects, and if possible, practice using them before the interview to boost your confidence.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities and attention to detail. Think of specific scenarios where you had to manage documentation under pressure or resolve compliance issues. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly.
✨Communicate Your Teamwork Experience
This role involves liaising with clients and working with internal teams, so highlight your communication and teamwork skills. Share examples of how you've collaborated with others to achieve project goals, and emphasise your positive attitude and ability to adapt to changing situations.