At a Glance
- Tasks: Lead TMF operations for clinical studies and ensure compliance with regulations.
- Company: Join a global CRO dedicated to innovative clinical research.
- Benefits: Inclusive culture, career growth, and the chance to make a real impact.
- Other info: Dynamic environment with opportunities for collaboration and creativity.
- Why this job: Be part of a mission-driven team improving lives through clinical trials.
- Qualifications: University degree preferred and 1-3 years in a regulated industry.
The predicted salary is between 35000 - 45000 £ 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.
What Records Management Compliance Department does 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:
- Perform RMC Lead Activities for 1-3 Studies.
- Support TMF set-up, coordinate ‘Requests for Sites to be added in eTMF’ between Project Teams (PT) and eTMF administrators; review eTMF access and coordinate updates, as necessary.
- Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF.
- Oversee the QC process and makes sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly.
- Prepare, maintain, and share TMF metrics and spreadsheets for assigned studies with Project Teams and Sponsors.
- Review TMF Key Performance Indicators (KPIs) and makes sure that TMF KPIs are in compliance.
- Support Regulatory and Sponsor audits and audits finding resolution, where necessary.
What you will bring to the role:
- Excellent written and verbal communication skills to clearly and concisely present information.
- Strong interpersonal skills.
- Ability to handle multiple, highly detailed tasks with exceptional accuracy.
- Strong planning and organizational skills.
- Proficiency in Microsoft Word and Excel.
Your experience:
- University Degree preferred (Life Science desirable).
- 1-3 years of relevant experience.
- Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Company industry.
We love knowing that someone is going to have a better life because of the work we do.
Senior Associate I, TMF Operations - UK employer: Worldwide Clinical Trials
Worldwide Clinical Trials is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals passionate about clinical research. With a strong emphasis on employee growth, the company offers numerous opportunities for skill development and career advancement, all while working in a diverse environment that values creativity and teamwork. Located in a vibrant area, employees benefit from a supportive atmosphere that encourages meaningful contributions to patient engagement activities.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Associate I, TMF Operations - UK
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their mission and values, especially how they relate to improving lives. This will help you tailor your responses and show that you’re genuinely interested in being part of their team.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers. Focus on articulating your experience clearly and confidently, especially around compliance and regulatory knowledge, as these are key in TMF Operations.
✨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 proactive and really keen on joining our innovative team at Worldwide Clinical Trials.
We think you need these skills to ace Senior Associate I, 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 how your values align with our mission at Worldwide Clinical Trials.
Be Clear and Concise:Use clear and concise language to present your experience and skills. Remember, we’re looking for excellent communication skills, so make sure your application reflects that!
Highlight Relevant Experience:Make sure to showcase any relevant experience you have in the CRO or pharmaceutical industry. We love seeing how your background can contribute to our team’s success.
Apply Through Our Website:Don’t forget to apply through our careers page! It’s the best way for us to receive your application and get you started on this exciting journey with us.
How to prepare for a job interview at Worldwide Clinical Trials
✨Know Your Stuff
Make sure you understand the role of a Senior Associate in TMF Operations. Brush up on your knowledge of records management compliance, eTMF processes, and the importance of KPIs. Being able to discuss these topics confidently will show that you're serious about the position.
✨Showcase Your Communication Skills
Since excellent written and verbal communication is key for this role, prepare to demonstrate your skills during the interview. Think of examples where you've effectively communicated complex information or collaborated with teams. This will highlight your interpersonal abilities.
✨Be Organised and Detail-Oriented
The job requires handling multiple detailed tasks, so be ready to discuss how you manage your time and ensure accuracy. Bring examples of how you've successfully juggled various responsibilities in the past, especially in regulated environments.
✨Emphasise Your Passion for Impact
Worldwide Clinical Trials values passion and purpose. Be prepared to share why you want to work in clinical research and how you believe your contributions can make a difference in patients' lives. This will resonate well with their mission and culture.
