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 and build relationships with key stakeholders.
- 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 35000 - 45000 £ 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
Study Start-Up Specialist, IQVIA Biotech, United Kingdom in Stafford employer: IQVIA LLC
IQVIA Biotech is an exceptional employer, offering a dynamic and collaborative work 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. Located in Stafford, UK, this role provides the unique advantage of being part of a purpose-built CRO dedicated to serving biotech sponsors, ensuring that your contributions are impactful and meaningful.
StudySmarter Expert Advice🤫
We think this is how you could land Study Start-Up Specialist, IQVIA Biotech, United Kingdom in Stafford
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching IQVIA Biotech and understanding their values and projects. Tailor your responses to show how your experience aligns with their mission and the role of a Study Start-Up Specialist.
✨Tip Number 3
Practice your pitch! Be ready to explain why you're the perfect fit for the role. Highlight your clinical research experience and how it relates to the responsibilities of the position.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining the team at IQVIA Biotech.
We think you need these skills to ace Study Start-Up Specialist, IQVIA Biotech, United Kingdom in Stafford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Study Start-Up Specialist role. Highlight your relevant experience in clinical research and any specific skills that match the job description. We want to see how you can contribute to our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your background aligns with our mission at IQVIA Biotech. Keep it concise but impactful – we love a good story!
Showcase Your Regulatory Knowledge:Since this role involves a lot of regulatory work, make sure to highlight your understanding of GCP/ICH guidelines and any experience you have with regulatory documentation. We’re looking for someone who knows their stuff!
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, it shows us you’re serious about joining our team at IQVIA Biotech!
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. Being able to discuss these confidently will show that you understand the compliance aspect of the role, which is crucial for a Study Start-Up Specialist.
✨Showcase Your Organisational Skills
Prepare examples of how you've managed multiple projects or tasks in the past. This role requires strong organisational abilities, so be ready to demonstrate your multitasking skills and how you prioritise effectively.
✨Build Relationships
Think about how you've successfully collaborated with stakeholders in previous roles. Be prepared to share specific instances where your communication and relationship-building skills made a difference in project outcomes.
✨Prepare for Scenario Questions
Anticipate questions about how you'd handle specific challenges related to site activation and regulatory submissions. Practising your responses to these scenarios can help you articulate your problem-solving skills during the interview.
