The Director, Regional Head Site Management & Oversight provides strategic leadership for clinical site operations, ensuring the effective conduct and supervision of site management activities and oversight for clinical programs within the assigned region. This includes alignment with our overall strategy, adherence to international regulatory standards, and delivery within agreed timelines and budget. Acting as the strategic link between therapeutic areas and investigator sites, the role ensures high-quality execution of clinical programs. The Regional Head will lead both permanent and functional service-provider site management teams while cultivating strong strategic partnerships with service providers and CROs. The Regional Head will also develop strong and lasting relationships within Medical Affairs at the regional level and with HCPs.
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
Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs
Provide local site intelligence to feasibility teams
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology
~Experience in leading and managing a professional team with strong experience in site management, 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
~ Must have experience as a mentor and coach others through peer‐to‐peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities
~ Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges
~ CSL Behring is a global biotherapeutics leader driven by our promise to save lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. 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.