At a Glance
- Tasks: Support clinical trial site activation and ensure compliance with regulations.
- Company: Join IQVIA Biotech, a leader in clinical research services.
- Benefits: Dynamic work environment, career growth opportunities, and collaboration with experts.
- Other info: Work remotely while building relationships in a global organisation.
- Why this job: Make a real impact on patient outcomes through innovative studies.
- Qualifications: Bachelor’s degree in Life Sciences and 3 years of clinical research experience.
The predicted salary is between 40000 - 50000 £ per year.
IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.
We are seeking a highly motivated Regulatory & Start-Up Specialist to support clinical trial site activation activities across the UK. In this role, you will play a pivotal part in ensuring studies are initiated efficiently, compliantly, and in alignment with regulatory requirements, SOPs, and project timelines. You will collaborate cross-functionally and act as a key liaison between sites, project teams, and internal stakeholders, contributing to the successful delivery of clinical trials.
Key Responsibilities- Act as the Single Point of Contact (SPOC) for assigned studies, supporting investigative sites, Site Activation Managers (SAMs), Project Management, and internal teams
- Deliver site start-up and activation activities in compliance with local and international regulations, SOPs, and work instructions
- Prepare and review regulatory documentation, ensuring completeness, accuracy, and timely submission
- Maintain and update internal systems, databases, and tracking tools with study-specific information
- Monitor site performance and provide feedback on metrics and deliverables
- Support study start-up timelines, identifying risks and implementing contingency plans as required
- Track and follow up on the progress of regulatory approvals, ethics submissions, contracts, ICFs, and Investigator Pack (IP) releases
- Ensure timely distribution of approved documents to sites and project teams
- Provide local regulatory expertise to study teams during planning and execution phases
- Perform quality control checks on site documentation
- Build effective relationships with stakeholders, including occasional interaction with sponsors
- Bachelor’s degree in Life Sciences or a related field
- Minimum 3 years of clinical research experience
- Strong understanding of clinical systems, processes, and corporate standards
- Sound knowledge of GCP/ICH guidelines and regulatory requirements
- Experience within a regulated clinical trial environment and understanding of the drug development lifecycle
- Excellent communication and stakeholder management skills
- Strong organizational and multitasking abilities
- Ability to work independently and prioritize effectively across multiple projects
- Confident in negotiation and influencing, with the ability to challenge constructively
- Detail-oriented with a strong focus on quality and compliance
- Ability to build and maintain collaborative relationships with internal and external stakeholders
- Be part of a dynamic and collaborative clinical research environment
- Contribute to innovative studies that improve patient outcomes
- Access to career development and growth opportunities
- Work alongside experienced professionals in a global organization
Remote Clinical Start-Up Regulatory Specialist in Stafford employer: IQVIA LLC
IQVIA Biotech is an exceptional employer, offering a dynamic and collaborative environment where you can contribute to innovative clinical studies that significantly improve patient outcomes. With a strong focus on employee growth, you will have access to career development opportunities while working alongside experienced professionals in a global organisation, all from the comfort of your home in Stafford, UK.
StudySmarter Expert Advice🤫
We think this is how you could land Remote Clinical Start-Up Regulatory Specialist in Stafford
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Show us you’re genuinely interested in what we do at IQVIA Biotech, and be ready to discuss how your skills align with our mission.
✨Tip Number 3
Practice your pitch! Be clear about your experience and how it relates to the role of a Regulatory & Start-Up Specialist. We want to hear how you can contribute to our team right from the start.
✨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 us you’re serious about joining our team.
We think you need these skills to ace Remote Clinical Start-Up Regulatory Specialist in Stafford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of a Regulatory & Start-Up Specialist. Highlight your relevant experience in clinical research and any specific skills that match the job description. We want to see how you fit into our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical trials and how your background makes you the perfect fit for this role. Let us know what excites you about working with StudySmarter.
Showcase Your Attention to Detail:As a Regulatory & Start-Up Specialist, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to present their best work right from the start!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at IQVIA LLC
✨Know Your Regulations
Make sure you brush up on GCP/ICH guidelines and local regulatory requirements before the interview. Being able to discuss these confidently will show that you understand the compliance landscape, which is crucial for a Regulatory & Start-Up Specialist.
✨Showcase Your Experience
Prepare specific examples from your past clinical research experience that highlight your ability to manage site activation activities. Use the STAR method (Situation, Task, Action, Result) to structure your responses and demonstrate your impact.
✨Communicate Effectively
Since this role involves liaising with various stakeholders, practice articulating your thoughts clearly and concisely. Think about how you can convey complex information in an understandable way, as strong communication skills are key in this position.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to clinical trials and their expectations for the role. This not only shows your interest but also helps you gauge if the company culture aligns with your values and work style.
