What are the responsibilities and job description for the Senior Site Management and Monitoring Oversight Lead position at CSL?
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next Senior Site Management and Monitoring Oversight Lead? The job is in our King of Prussia PA, Waltham MA or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Senior Director Head of Site Management & Monitoring.
You will be 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.
Site Oversight Execution
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.
Qualifications And Experience Requirements
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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!
Could you be our next Senior Site Management and Monitoring Oversight Lead? The job is in our King of Prussia PA, Waltham MA or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Senior Director Head of Site Management & Monitoring.
You will be 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.
Site Oversight Execution
- Ensure effective sponsor oversight of investigational sites by reviewing monitoring visit reports, site communications, and issue resolution documentation.
- Support the development and execution of study-specific monitoring plans, ensuring alignment with protocol requirements and risk-based monitoring strategies.
- Monitor site-level performance metrics (e.g., enrollment, data quality, protocol adherence) and escalate concerns to study leadership as needed.
- Partner with CROs and external service providers to ensure consistent and compliant site management practices across assigned studies.
- Contribute to audit and inspection preparedness by validating site documentation, ensuring timely issue resolution, and maintaining oversight logs.
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.
Qualifications And Experience Requirements
- Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
- 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
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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!
