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- Tasks: Manage and review essential documents for clinical trials with a focus on quality and compliance.
- Company: Join a global CRO dedicated to innovative solutions in clinical research.
- Benefits: Inclusive culture, career growth opportunities, and a chance to make a real impact.
- Other info: Dynamic work environment with supportive teams and accessible leaders.
- Why this job: Be part of a mission-driven team improving lives through groundbreaking clinical research.
- Qualifications: Administrative experience and strong attention to detail are key.
The predicted salary is between 30000 - 40000 £ per year.
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
The Records Management Compliance Department at Worldwide TMF Operations handles the processing, maintenance and archiving of all essential documents in strict accordance with pertinent Standard Operating Procedures, country-specific regulations, and industry best practices. Throughout Worldwide Clinical Trials, our culture of collaboration and innovation is what propels us in our pursuit of 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 the opportunity to regularly collaborate with members of the Worldwide Project Team.
What you will do:
- Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
- Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.
- Prepare periodic TMF Quality Control checklists for review by Project Team review.
- Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
- Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
What you will bring to the role:
- 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.
- Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment.
- Handle multiple, highly detailed tasks with exceptional accuracy.
- Demonstrate strong planning and organizational skills.
- Demonstrate proficiency in Microsoft Word and Excel.
- Develop proficiency in use of an electronic document repository or eTMF.
- General understanding of clinical research principles and processes.
Your experience:
- Minimum 6 months of administrative experience, preferably but not strictly in the CRO or Pharma industry.
- Knowledge of working within a highly regulated industry (desirable).
- A strong, long‑term interest in administrative‑focused work, with close attention to detail and comfort handling routine, process‑driven tasks.
We love knowing that someone is going to have a better life because of the work we do.
Associate II, TMF Operations - UK employer: Worldwide Clinical Trials
Contact Detail:
Worldwide Clinical Trials Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate II, TMF Operations - UK
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Worldwide Clinical Trials on LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by understanding the TMF Operations role inside out. Brush up on your knowledge of clinical research principles and be ready to discuss how your skills align with their mission to improve lives.
✨Tip Number 3
Showcase your attention to detail during the interview. Bring examples of how you've handled complex tasks in the past, especially in fast-paced environments. This will demonstrate that you can thrive in their dynamic setting.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining the team at Worldwide.
We think you need these skills to ace Associate II, TMF Operations - UK
Some tips for your application 🫡
Show Your Passion: When writing your application, let your passion for improving lives shine through. We want to see that you care about making a difference and are excited about the role.
Tailor Your CV: Make sure your CV is tailored to the Associate II, TMF Operations role. Highlight relevant experience and skills that match the job description, especially your attention to detail and organisational skills.
Be Clear and Concise: Use clear and concise language in your application. We appreciate straightforward communication, so avoid jargon and get straight to the point about your qualifications and experiences.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re serious about joining our team.
How to prepare for a job interview at Worldwide Clinical Trials
✨Know Your TMF Inside Out
Make sure you understand the Trial Master File (TMF) processes and the importance of compliance in clinical research. Brush up on relevant Standard Operating Procedures (SOPs) and be ready to discuss how you can contribute to maintaining high-quality standards.
✨Showcase Your Attention to Detail
Since this role requires handling multiple detailed tasks, prepare examples from your past experiences that highlight your attention to detail. Discuss how you've successfully managed complex documents or projects while ensuring accuracy and adherence to regulations.
✨Communicate Clearly and Confidently
Excellent communication skills are key for this position. Practice articulating your thoughts clearly, both verbally and in writing. You might even want to prepare a few questions about the company’s culture and values to demonstrate your interest in collaboration and innovation.
✨Demonstrate Your Organisational Skills
Be ready to talk about how you prioritise tasks and manage your time effectively in a fast-paced environment. Share specific strategies or tools you use to stay organised, especially when dealing with tight deadlines and multiple responsibilities.