About

• Position Description and Summary The Site Management and Monitoring Oversight 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 study and site-level activities, and ensuring that monitoring plans and tools adequately address protocol-specific risks. Main Responsibilities Clinical Oversight & Compliance Responsible for operational oversight of the site, site health and monitoring activities Support QA audit and inspection planning, and implementation of CAPAs as needed Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs Study Delivery Support Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts Support sites in understanding study expectations, timelines, and required deliverables Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs Site Relationship & Engagement Build and maintain strong, trusted relationships with investigators and site staff – Face of CSL Serve as the sponsor primary point of contacted for assigned studies Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration Continuous Improvement & Site Experience Collect feedback from sites and advocate for process simplification and burden reduction internally Identify opportunities to improve study materials, and operational processes Represent the “voice of the site” in cross-functional discussions and initiatives Feasibility & Site Selection Provide local site intelligence to feasibility teams Support site development Qualifications and Experience Requirements Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology 12 years + relevant clinical research (or related) experience within the pharmaceutical industry Experience in leading and managing a professional team along with site management, monitoring and overseeing large and/or complex global clinical trials Extensive experience in drug development process and specifically, each step within the clinical trial process Thorough knowledge of ICH guidelines/GCP for all stages in clinical development process Experience in overseeing Vendors and CROs Robust budget forecasting and management experience 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 Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges 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. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL 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. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. CSL is an Equal Opportunity Employer. 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