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- Tasks: Lead site management and monitoring for impactful clinical trials in a dynamic biotech environment.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Prioritise your well-being with competitive benefits and a supportive work culture.
- Why this job: Make a real difference in patients' lives while advancing your career in clinical research.
- Qualifications: 7+ years in clinical research with strong leadership and project management skills.
- Other info: Be part of an inclusive team that values diversity and innovation.
The predicted salary is between 36000 - 60000 £ per year.
CSL\’s R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
The Senior Site Management and Monitoring Oversight Lead 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 site-level activities, and ensuring that monitoring plans and tools adequately address protocol-specific risks.
Main Responsibilities and Accountabilities:
Site Oversight Execution
- Ensure effective sponsor oversight of investigational sites by reviewing monitoring visit reports, site communications, and issue resolution documentation.
Monitoring Plan Implementation
- Support the development and execution of study-specific monitoring plans, ensuring alignment with protocol requirements and risk-based monitoring strategies.
Performance Tracking
- Monitor site-level performance metrics (e.g., enrollment, data quality, protocol adherence) and escalate concerns to study leadership as needed.
Vendor Collaboration
- Partner with CROs and external service providers to ensure consistent and compliant site management practices across assigned studies.
Compliance & Inspection Readiness
- Contribute to audit and inspection preparedness by validating site documentation, ensuring timely issue resolution, and maintaining oversight logs.
In addition
- Act as the primary point of contact both internally and externally (e.g., vendors) as applicable for anything study related.
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.
- Support audits/inspections and resolutions of findings.
- Support in the development of new SOPs, guidelines etc and/ or participate in working groups about new processes.
- Mentor and training more junior staff on processes and procedures.
Job Qualifications and Experience Requirements:
Education
At minimum, bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
Experience
- As a guide, a minimum of 7 years’ relevant clinical research (or related) experience within the pharmaceutical industry.
- Previous experience in leading and managing a team of professional staff.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
- Experience in site management and monitoring and overseeing large and/or complex global clinical trials.
- Robust budget forecasting and management experience.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Competencies
- Demonstrated ability to lead teams and work in a fast-paced team environment.
- Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment
- 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.
- Ability to evaluate, judge and make decisions regarding staff. Ability to teach/coaching and setting an example of ‘best practice’.
- Excellent interpersonal and decision-making skills.
- Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
- 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.
- Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.
- Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge.
- Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and complex clinical programs.
- Excellent written and oral communication skills and maintains computer literacy in appropriate software.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL
Do work that matters at CSL Behring!
Senior Site Management and Monitoring Oversight Lead employer: CSL Behring
Contact Detail:
CSL Behring Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Site Management and Monitoring Oversight Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by researching CSL Behring and understanding their mission. Tailor your responses to show how your experience aligns with their goals, especially in site management and monitoring oversight.
✨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 leading teams and managing clinical trials.
✨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 genuinely interested in being part of our innovative team at CSL.
We think you need these skills to ace Senior Site Management and Monitoring Oversight Lead
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Site Management and Monitoring Oversight Lead role. Highlight your relevant experience in clinical trials and site management, and don’t forget to mention any specific achievements that align with the job description.
Showcase Your Skills: We want to see your skills shine! Be sure to include examples of your leadership and project management abilities. Mention how you've successfully navigated complex clinical trials and collaborated with teams in a matrix environment.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon where possible. This will help us quickly understand your qualifications and fit for the role.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the position. Plus, it’s super easy to do!
How to prepare for a job interview at CSL Behring
✨Know Your Stuff
Make sure you have a solid understanding of the drug development process and clinical trial phases. Brush up on ICH guidelines and GCP, as these will likely come up in conversation. Being able to discuss specific examples from your experience will show that you’re not just familiar with the theory but can apply it in practice.
✨Show Your Leadership Skills
As a Senior Site Management and Monitoring Oversight Lead, you'll need to demonstrate your ability to lead teams effectively. Prepare to share examples of how you've managed teams in the past, resolved conflicts, and mentored junior staff. Highlighting your interpersonal skills will be key!
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving abilities in real-world situations. Think about challenges you've faced in site management or monitoring and how you overcame them. This will help interviewers gauge your critical thinking and decision-making skills.
✨Engage with the Interviewers
Don’t just wait for questions; engage with your interviewers by asking insightful questions about their current projects or challenges they face. This shows your genuine interest in the role and helps you understand if the company culture aligns with your values.