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- Tasks: Manage anonymisation of clinical trial documents for public disclosure and support global transparency initiatives.
- Company: Join a leading global biotech organisation with a collaborative culture.
- Benefits: Fully remote role, competitive salary, and opportunities for professional growth.
- Other info: Dynamic environment with minimal travel and excellent career advancement opportunities.
- Why this job: Make a real impact in clinical research while working with innovative teams.
- Qualifications: Bachelor’s degree and 3 years’ experience in pharma or biotech required.
The predicted salary is between 40000 - 50000 £ per year.
Advanced Clinical is supporting a global biotech organisation in the search for a Clinical Trial Transparency Anonymisation Specialist to join their growing Clinical Operations / Trial Disclosure team. This is an excellent opportunity for someone with experience in clinical trial disclosure, transparency, anonymisation, or regulatory document publishing who is looking to work within a highly collaborative global environment.
Key Responsibilities:
- Manage anonymisation of clinical trial documents and datasets for public disclosure
- Support EU CTR, ClinicalTrials.gov, EMA Policy 0070, and Health Canada PRCI submissions
- Develop anonymisation strategies and assess re-identification risk in line with GDPR guidance
- Collaborate with Biostatistics, Programming, Medical Writing, and Regulatory Operations teams
- Perform quality review of redacted/anonymised documents
- Support transparency and data-sharing initiatives globally
Requirements:
- Bachelor’s degree in a scientific or technical discipline
- Minimum 3 years’ experience within pharma, biotech, or CRO environments
- Experience with clinical trial transparency/disclosure activities
- Knowledge of EU CTR, EMA Policy 0070, ClinicalTrials.gov, or related regulations
- Understanding of anonymization/redaction methodologies and disclosure processes
- Strong communication and organisational skills
- Experience with document management systems and analytical tools
Fully remote role within the UK with minimal travel requirements.
Regulatory Operations Specialist employer: Advanced Clinical
Contact Detail:
Advanced Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Operations Specialist
✨Tip Number 1
Network like a pro! Reach out to folks in the biotech and pharma sectors on LinkedIn. Join relevant groups and engage in discussions to get your name out there. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of clinical trial transparency and anonymisation. We recommend creating a cheat sheet of key regulations like EU CTR and EMA Policy 0070. This will help you sound super knowledgeable and confident!
✨Tip Number 3
Don’t forget to showcase your collaborative spirit! In your conversations, highlight examples of how you’ve worked with cross-functional teams. We want to see that you can play well with others, especially in a global environment.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to connect directly with us. Let’s make this happen together!
We think you need these skills to ace Regulatory Operations Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Regulatory Operations Specialist. Highlight your experience in clinical trial transparency and anonymisation, and don’t forget to mention any relevant regulations you’re familiar with, like EU CTR or EMA Policy 0070.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about clinical trial transparency and how your background makes you a perfect fit for our team. Keep it concise but engaging!
Showcase Your Skills: In your application, be sure to showcase your strong communication and organisational skills. We want to see how you’ve used these in past roles, especially in collaborative environments like pharma or biotech.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status directly!
How to prepare for a job interview at Advanced Clinical
✨Know Your Regulations
Make sure you brush up on the key regulations like EU CTR, EMA Policy 0070, and ClinicalTrials.gov. Being able to discuss these confidently will show that you’re not just familiar with the role but also understand the regulatory landscape.
✨Showcase Your Anonymisation Skills
Prepare examples of how you've managed anonymisation in past roles. Be ready to discuss specific strategies you've developed and how you assessed re-identification risks, as this is crucial for the position.
✨Collaborative Spirit
Since the role involves working with various teams, think of instances where you successfully collaborated with others, especially in a clinical or regulatory context. Highlight your communication skills and how they contributed to successful outcomes.
✨Quality Matters
Be prepared to talk about your experience with quality reviews of redacted documents. Discuss any tools or methodologies you’ve used to ensure accuracy and compliance, as this will demonstrate your attention to detail and commitment to high standards.