At a Glance
- Tasks: Lead clinical site management and ensure high-quality trial execution.
- Company: CSL Behring, a global leader in biotherapeutics focused on saving lives.
- Benefits: Comprehensive benefits package and a commitment to employee well-being.
- Other info: Join a diverse team dedicated to improving patient lives globally.
- Why this job: Make a real impact in clinical research while working with innovative therapies.
- Qualifications: 10+ years in clinical research and strong leadership skills required.
The predicted salary is between 43200 - 72000 £ per year.
Accountable for the strategic and operational oversight of investigational site management and monitoring activities across assigned clinical studies or programs. This role ensures that clinical trials are executed with high quality, regulatory compliance, and operational efficiency, in alignment with global clinical development strategies. Operating within a matrix environment, this role partners with internal stakeholders and external service providers to develop and implement study-specific oversight plans, monitor site performance, and proactively identify and mitigate risks. The role is pivotal in maintaining sponsor oversight, validating the effectiveness of study and site-level activities, and ensuring that monitoring plans and tools adequately address protocol-specific risks.
This role plays a pivotal role in building and managing meaningful productive relationships with KOLs and key investigator sites.
Main Responsibilities- Clinical Oversight & Compliance
- Responsible for operational oversight of the site, site health and monitoring activities.
- Support QA audit and inspection planning, and implementation of CAPAs as needed.
- Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs.
- Study Delivery Support
- Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts.
- Support sites in understanding study expectations, timelines, and required deliverables.
- Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs.
- Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs.
- Site Relationship & Engagement
- Build and maintain strong, trusted relationships with investigators and site staff.
- Serve as the sponsor primary point of contact for assigned studies.
- Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration.
- This role will require travel to Investigator Meetings, Investigator sites and CROs. Anticipated travel >50%.
- Continuous Improvement & Site Experience
- Collect feedback from sites and advocate for process simplification and burden reduction internally.
- Identify opportunities to improve study materials, and operational processes.
- Represent the voice of the site in cross-functional discussions and initiatives.
- Feasibility & Site Selection
- Provide local site intelligence to feasibility teams.
- Support site development.
- Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology.
- 10 years + clinical research experience within the pharmaceutical industry.
- Experience in leading/managing a team as well as in site management, monitoring and overseeing large and/or complex global clinical trials.
- Must have a strong understanding and experience in drug development process and specifically each step within the clinical trial process.
- Must have strong budget forecasting and management experience.
- Extensive experience and knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
- Experience/ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities.
- Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges.
- Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.
Lead Clinical Site Ambassador (Remote) in Guernsey employer: CSL Behring
CSL Behring is an exceptional employer that prioritises employee well-being and professional growth, offering a dynamic work culture that fosters innovation and collaboration. With a commitment to inclusion and belonging, employees are encouraged to thrive in their roles while contributing to life-saving therapies for patients worldwide. The remote nature of the Lead Clinical Site Ambassador position allows for flexibility, while the opportunity to engage with key opinion leaders and investigator sites ensures meaningful and impactful work.
StudySmarter Expert Advice🤫
We think this is how you could land Lead Clinical Site Ambassador (Remote) in Guernsey
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a Lead Clinical Site Ambassador role or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s mission and values. Understand CSL Behring's focus on innovation and patient care, and be ready to discuss how your experience aligns with their goals. Show them you’re not just another candidate, but someone who truly gets what they’re about!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. Focus on articulating your experience in site management and compliance, as these are key areas for the role.
✨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 serious about joining the CSL Behring team and contributing to their mission of saving lives.
We think you need these skills to ace Lead Clinical Site Ambassador (Remote) in Guernsey
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your relevant experience in clinical research and site management. We want to see how your skills align with the Lead Clinical Site Ambassador role, so don’t hold back!
Showcase Your Achievements:When detailing your experience, focus on specific achievements that demonstrate your ability to manage clinical trials effectively. Use metrics where possible to show how you’ve improved site performance or compliance.
Be Clear and Concise:Keep your application straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out. This will help us quickly see why you’re a great fit for the role.
Apply Through Our Website:We encourage you to submit your application directly through our website. It’s the best way to ensure your application gets into the right hands and shows your enthusiasm for joining our team at StudySmarter!
How to prepare for a job interview at CSL Behring
✨Know Your Clinical Trials Inside Out
Make sure you’re well-versed in the specifics of clinical trial processes, especially those relevant to the role. Brush up on ICH guidelines and GCP standards, as these will likely come up during your interview. Being able to discuss your experience with operational oversight and risk mitigation will show that you’re ready for the challenges of the Lead Clinical Site Ambassador position.
✨Showcase Your Relationship-Building Skills
This role is all about building strong relationships with investigators and site staff. Prepare examples of how you've successfully engaged with stakeholders in the past. Highlight your ability to understand site capabilities and constraints, as this will demonstrate your strategic thinking and collaborative approach.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific site-related challenges or escalated issues. Think through potential scenarios related to recruitment, retention, or compliance, and be ready to discuss your problem-solving strategies. This will help you illustrate your proactive mindset and operational efficiency.
✨Demonstrate Your Leadership Experience
Since the role involves leading teams and mentoring others, be prepared to talk about your leadership style and experiences. Share examples of how you've managed teams in complex clinical projects and how you’ve helped develop others' skills. This will show that you can not only oversee operations but also inspire and grow your team.
