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
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