At a Glance
- Tasks: Lead clinical studies, ensuring compliance and efficient trial launches.
- Company: Join Roche, a global leader in healthcare innovation.
- Benefits: Competitive salary, flexible working, and opportunities for personal growth.
- Other info: Collaborative culture that values diversity and encourages personal expression.
- Why this job: Make a real impact on patient care through innovative clinical research.
- Qualifications: Degree in a scientific field and experience in clinical operations required.
The predicted salary is between 50000 - 65000 £ per year.
At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally.
We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster.
Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption, and reimbursement globally so we can save lives and improve patient quality of life.
The Opportunity
As a Lead Clinical Site Manager specialising in IVDR and Study Start-Up, you will be responsible for designing, planning, coordinating, and independently conducting all activities involved in initiating, monitoring, and completing clinical research studies. You will play a vital role in ensuring studies are delivered, recorded, and reported in accordance with protocols, standard operating procedures, and global regulatory guidelines.
- Lead end-to-end study start-up activities, driving site selection, activation, and qualification assessments to ensure clinical trials launch efficiently and are compliance-ready.
- Manage Ethics Committee (EC) and Competent Authority (CA) submissions, ensuring all trial documentation, local contracts, and institutional approvals meet stringent regulatory timelines.
- Provide robust CRO oversight, monitoring external partner deliverables, tracking milestones, and ensuring vendor performance aligns with Roche quality standards.
- Act as the primary contact and clinical trial expert for assigned study site personnel, providing training, technical assistance, and coordinating necessary certifications.
- Develop critical study documentation, including Study Monitoring Plans, informed consent documents, patient instruction guides, and case report forms tailored to diagnostic protocols.
- Deliver comprehensive site monitoring and data validation activities, executing site visits throughout all study phases from early start-up to final close-out.
- Collaborate cross-functionally with global, local, and virtual teams, across Research & Development, Study Management, and Biometrics to deliver top-tier clinical diagnostic solutions.
- Leadership & Coaching: You will dedicate time to coaching colleagues, helping others develop their skills, and acting as a resource for less-experienced team members.
Who You Are
You are a proactive, collaborative, and highly organised clinical research professional who thrives in a fast-paced, matrixed environment. You possess strong problem-solving skills, make sound independent decisions, and excel at managing external vendor relationships. To be successful in this role, you bring:
- Education & Experience: A degree in a scientific discipline or related field (or equivalent combination of education and experience) combined with a proven track record in clinical operations or clinical trial coordination.
- Study Start-Up & Submission Expertise: Direct experience in Clinical Operations, specifically managing Ethics Committee (EC) and Competent Authority (CA) regulatory submissions.
- Vendor Management: Demonstrated experience in CRO oversight, with the ability to effectively monitor external partner deliverables and keep study timelines on track.
- IVDR & Regulatory Knowledge: Strong understanding of In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) frameworks alongside global standards such as ICH-GCP guidelines and FDA regulations.
- Stakeholder Engagement: Exceptional verbal and written communication skills (English) with a proven ability to build trusted relationships and influence cross-functional partners.
At Roche, you’ll thrive in a culture that values different perspectives and creates a place of belonging, where we challenge ourselves to excel and achieve strong results, together.
Let’s create a healthier, brighter future for all.
Senior Clinical Site Lead - Study Start-Up & IVDR in Burgess Hill employer: F. Hoffmann-La Roche AG
At Roche, we pride ourselves on fostering a culture of inclusivity and collaboration, where every employee is valued for their unique contributions. Our Burgess Hill location offers a dynamic work environment that encourages personal growth and professional development, with ample opportunities for coaching and mentorship. Join us in our mission to innovate healthcare solutions that make a global impact, while enjoying the benefits of a supportive workplace that prioritises your well-being and career advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Site Lead - Study Start-Up & IVDR in Burgess Hill
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about introducing yourself. 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 Roche's mission and values, and think about how your experience aligns with their goals. This will help you stand out as a candidate who truly gets what they’re about.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online resources to refine your answers. Focus on articulating your experience in clinical operations and how it relates to the role of Lead Clinical Site Manager.
✨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 genuinely interested in joining Roche and being part of our mission to improve healthcare.
We think you need these skills to ace Senior Clinical Site Lead - Study Start-Up & IVDR in Burgess Hill
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that match the Senior Clinical Site Lead role. Highlight your expertise in study start-up and IVDR, as well as any relevant regulatory knowledge.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're the perfect fit for this position. Share your passion for clinical research and how your background aligns with our mission at Roche. Be genuine and let your personality shine through!
Showcase Your Achievements:When detailing your experience, focus on your achievements rather than just responsibilities. Use metrics or specific examples to demonstrate how you've successfully managed studies or improved processes in the past.
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. This way, we can ensure your application gets the attention it deserves and you can easily track your progress!
How to prepare for a job interview at F. Hoffmann-La Roche AG
✨Know Your IVDR Inside Out
Make sure you brush up on the In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR). Be prepared to discuss how these regulations impact clinical trials and your previous experiences with compliance. This shows you’re not just familiar with the terms, but you understand their practical implications.
✨Showcase Your Leadership Skills
As a Lead Clinical Site Manager, you'll need to demonstrate your leadership abilities. Prepare examples of how you've successfully led teams or projects in the past, especially in fast-paced environments. Highlight your coaching experiences and how you've helped others develop their skills.
✨Master the Art of Communication
Exceptional verbal and written communication skills are crucial for this role. Practice articulating your thoughts clearly and concisely. You might even want to prepare a few questions to ask during the interview that show your interest in collaboration and stakeholder engagement.
✨Be Ready for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and decision-making abilities. Think of specific situations where you had to manage external vendor relationships or navigate regulatory submissions. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
