Senior Site Management and Monitoring Oversight Lead
Join to apply for the Senior Site Management and Monitoring Oversight Lead role at CSL
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.
Responsibilities
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.
Additional Responsibilities
* Act as the primary point of contact internally and externally (e.g., vendors) 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 the development of new SOPs, guidelines, etc., and participate in working groups about new processes.
* Mentor and train junior staff on processes and procedures.
Qualifications
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
* Minimum of 7 years of relevant clinical research (or related) experience within the pharmaceutical industry.
* Previous experience leading and managing a team of professional staff.
* Solid understanding of the drug development process, 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.
* Experience working within a matrix environment and ability to resolve interpersonal difficulties.
* Successful mentoring and coaching of others through peer‑to‑peer interactions and development of reporting personnel.
* Ability to evaluate, judge, and make decisions regarding staff; ability to teach/coaching and set an example of best practice.
* Excellent interpersonal and decision‑making skills.
* Demonstrated innovation and drive to deliver program objectives.
* Skilled at navigating new or novel indications, study/program approaches, and unique challenges.
* Excellent understanding of all tasks involved in a clinical development program.
* Ability to plan and ensure execution and completion of clinical programs to the highest ethical and scientific standards.
* Extensive knowledge of ICH guidelines/GCP; maintains current medical/scientific/regulatory knowledge.
* Demonstrated project management skills including simultaneous management of multiple projects.
* Problem‑solving and clear judgment in interacting with external parties, timelines, and complex clinical programs.
* Excellent written and oral communication skills and computer literacy.
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.
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 a variety of 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. Inclusion and belonging is at the core of our mission and who we are. 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.
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