Senior Site Management and Monitoring Oversight Lead
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.
Reporting to the Senior Director Head of Site Management and 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, partnering 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.
Your Responsibilities will include
- 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 elevate 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
- 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 resolution of findings
- Support in the development of new SOPs, guidelines, etc., and/or participate in working groups about new processes
Your Skills & Experience
- 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 skilled 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 is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people.
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