At a Glance
- Tasks: Lead oversight of clinical trials, ensuring quality and compliance while managing site relationships.
- Company: CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Competitive salary, remote work options, and opportunities for professional growth.
- Other info: Join a dynamic team focused on continuous improvement and patient-centric solutions.
- Why this job: Make a real impact in clinical research and improve patient lives through innovative therapies.
- Qualifications: 12+ years in clinical research with strong leadership and site management experience.
The predicted salary is between 48000 - 72000 £ per year.
The Site Management and Monitoring Oversight is 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.
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 – Face of CSL
- 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
- 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
Qualifications and Experience Requirements
- Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology
- 12 years + relevant clinical research (or related) experience within the pharmaceutical industry
- Experience in leading and managing a professional team along with site management, monitoring and overseeing large and/or complex global clinical trials
- Extensive experience in drug development process and specifically, each step within the clinical trial process
- Thorough knowledge of ICH guidelines/GCP for all stages in clinical development process
- Experience in overseeing Vendors and CROs
- Robust budget forecasting and management experience
- Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities
- Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report
- Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges
Associate Director Site Mgt & Oversight Lead (Remote) employer: CSL
CSL Behring is an exceptional employer that prioritises employee growth and development, offering a dynamic work culture that fosters collaboration and innovation. With a commitment to saving lives through cutting-edge biotherapeutics, employees enjoy the benefits of working in a global leader while having the flexibility of a remote role, allowing for a healthy work-life balance and the opportunity to make a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Site Mgt & Oversight Lead (Remote)
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can land you that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. We recommend practising common interview questions and even role-playing with a friend. The more prepared you are, the more confident you’ll feel when it’s time to shine!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the position. We suggest mentioning something specific from the interview to remind them of your conversation and keep you top of mind.
✨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, we often have exclusive opportunities listed there that you won’t find anywhere else.
We think you need these skills to ace Associate Director Site Mgt & Oversight Lead (Remote)
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Associate Director role. Highlight your relevant experience in clinical research and site management, and show us how you align with our mission at StudySmarter.
Showcase Your Achievements:Don’t just list your responsibilities; we want to see your impact! Use specific examples of how you've improved site performance or managed risks in previous roles to demonstrate your expertise.
Be Clear and Concise:Keep your application straightforward and to the point. We appreciate clarity, so make sure your writing is easy to read and free from jargon. This will help us understand your qualifications quickly.
Apply Through Our Website:We encourage you to submit your application directly through our website. This way, you’ll ensure it reaches the right people and you can easily track your application status!
How to prepare for a job interview at CSL
✨Know Your Stuff
Make sure you have a solid understanding of the clinical trial process and ICH guidelines. Brush up on your knowledge about site management and monitoring activities, as well as the specific responsibilities outlined in the job description. This will help you answer questions confidently and show that you're the right fit for the role.
✨Showcase Your Experience
Prepare to discuss your relevant experience in leading teams and managing complex global clinical trials. Have specific examples ready that demonstrate your ability to mitigate risks and improve site engagement. This will highlight your expertise and how it aligns with the company's needs.
✨Build Rapport
Since this role involves building strong relationships with investigators and site staff, practice how you'll establish rapport during the interview. Be personable and approachable, and think about how you can convey your commitment to collaboration and support for sites.
✨Ask Insightful Questions
Prepare thoughtful questions that show your interest in the company and the role. Inquire about their current challenges in site management or how they measure success in clinical trials. This not only demonstrates your enthusiasm but also gives you valuable insights into the company culture and expectations.
