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For Companies At a Glance
- Tasks: Manage essential documents and ensure compliance in clinical research.
- Company: Join a global leader in clinical trials with a culture of innovation.
- Benefits: Remote work, diverse team, and opportunities for professional growth.
- Why this job: Make a real impact on patients' lives while developing your skills.
- Qualifications: University degree preferred; up to 1 year of relevant experience.
- Other info: Inclusive environment that values creativity and collaboration.
The predicted salary is between 28800 - 43200 £ per year.
What Records Management Compliance Department Does
TMF Operations handles the processing, maintenance and archiving of all essential documents in strict accordance with Standard Operating Procedures, country‑specific regulations and industry best practices. Throughout Worldwide Clinical Trials, our culture of collaboration and innovation propels us in pursuing excellence in clinical research and making a meaningful impact on every patient's life. Roles within our TMF Operations department have a global scope, with opportunities to collaborate regularly with members of the Worldwide Project Team.
What You Will Do
- Fulfil the “TMF Approver” role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
- Process, review, and resolve rejected Trial Master File (TMF) documents for multiple studies in both electronic and hard‑copy format.
- Work with a variety of Electronic Document Management and eTMF Systems to review, classify and process Essential Documents.
- Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
- Escalate any TMF Quality issues in a timely manner to RMC Lead.
- Provide administrative support for the RMC Lead including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
- Perform additional tasks as assigned by the Line Manager.
What You Will Bring To The Role
- University Degree preferred (Life Science desirable).
- Up to 0‑1 year of relevant experience.
- Knowledge of working within a highly regulated industry (desirable).
- Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions.
- Possess excellent written and verbal communication skills to clearly and concisely present information.
- Work with internal teams and can execute tasks under general direction, seeking assistance as needed.
- Exercise sound judgment and ability to identify decisions requiring supervisory approval.
- Demonstrate proficiency in Microsoft Word and Excel.
- Develop proficiency in use of an electronic document repository or eTMF, and document recognition skills.
- General understanding of clinical research principles and processes.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritise attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.
Associate I, TMF Operations - Fixed term - EU/LATAM- Remote in Nottingham employer: Worldwide Clinical Trials
Contact Detail:
Worldwide Clinical Trials Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate I, TMF Operations - Fixed term - EU/LATAM- Remote in Nottingham
✨Tip Number 1
Network like a pro! Reach out to folks in the TMF Operations field on LinkedIn or at industry events. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by practising common questions related to TMF operations. Think about how your skills align with their needs, especially around document management and compliance. We want you to shine!
✨Tip Number 3
Show off your tech skills! Familiarise yourself with electronic document management systems and be ready to discuss your experience with Microsoft Word and Excel. It’s all about demonstrating your readiness to dive into the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace Associate I, TMF Operations - Fixed term - EU/LATAM- Remote in Nottingham
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the job description. Highlight any relevant experience in records management or clinical research, and don’t forget to mention your proficiency in Microsoft Word and Excel!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about TMF Operations and how your background aligns with our mission at Worldwide. Keep it concise but engaging – we want to see your personality!
Showcase Your Communication Skills: Since excellent written communication is key for this role, make sure your application is clear and free of errors. Use straightforward language and structure your thoughts logically. We love a well-organised application!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Worldwide Clinical Trials
✨Know Your TMF Basics
Before the interview, brush up on your knowledge of Trial Master Files (TMF) and their importance in clinical research. Understand the key processes involved in managing TMF documents, as this will show your potential employer that you’re serious about the role and have a grasp of the industry.
✨Showcase Your Communication Skills
Since excellent written and verbal communication is crucial for this position, prepare to demonstrate these skills during the interview. Think of examples where you've effectively communicated complex information or resolved issues, as this will highlight your ability to work with internal teams and report trends clearly.
✨Familiarise Yourself with Compliance Standards
Get to know the Standard Operating Procedures (SOPs) and compliance regulations relevant to TMF operations. Being able to discuss how you would adhere to these standards will impress your interviewers and show that you understand the importance of compliance in a highly regulated industry.
✨Prepare Questions About Team Collaboration
Since the role involves working closely with the Worldwide Project Team, think of insightful questions about team dynamics and collaboration. This not only shows your interest in the company culture but also gives you a chance to assess if it’s the right fit for you.
