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 independently while building 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 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.
Study Start-Up Specialist, IQVIA Biotech, United Kingdom in Stafford employer: IQVIA
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. The home-based role allows for flexibility, ensuring a healthy work-life balance as you play a pivotal part in the clinical trial process across the UK.
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 the company and role thoroughly. Understand IQVIA's mission and values, and think about how your skills align with their needs. This will help you stand out as a candidate who truly gets it.
✨Tip Number 3
Practice your responses to common interview questions. Use the STAR method (Situation, Task, Action, Result) to structure your answers. This will help you articulate your experiences clearly and confidently.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in showing your appreciation and keeping you top of mind for the hiring team. Plus, it’s a great chance to reiterate your interest in the role.
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 role of Regulatory & Start-Up Specialist. Highlight your relevant experience in clinical research and any specific skills that align with 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 this role and how your background makes you the perfect fit. Be sure to mention your understanding of regulatory requirements and your experience with site activation.
Showcase Your Communication Skills:Since this role involves liaising with various stakeholders, it's crucial to demonstrate your excellent communication skills. Use clear and concise language in your application, and don’t hesitate to share examples of how you've effectively managed relationships in the past.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of success. This way, your application goes straight to us, and we can review it promptly. Plus, it shows you're keen on joining our team at IQVIA Biotech!
How to prepare for a job interview at IQVIA
✨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 aspect of the role and can hit the ground running.
✨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 problem-solving skills.
✨Build Rapport with Stakeholders
Since this role involves liaising with various stakeholders, think about how you can demonstrate your communication and relationship-building skills. Be ready to share examples of how you've successfully collaborated with teams or managed stakeholder expectations in previous roles.
✨Be Detail-Oriented
As a Regulatory & Start-Up Specialist, attention to detail is crucial. During the interview, mention how you ensure accuracy in documentation and compliance. You might even want to bring a sample of your work (if appropriate) to showcase your meticulousness.
