CSL Seqirus is seeking a Director, Regional Head Site Mgmt & Oversight to provide strategic leadership for clinical site operations, ensuring effective conduct and supervision of site management activities and oversight for clinical programs within Europe. This role acts as the strategic link between therapeutic areas and investigator sites.
What You'll Do
- Provide 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.
- 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.
- Build and maintain strong, trusted relationships with investigators and site staff – acting as the face of CSL.
- Serve as the sponsor primary point of contact for assigned studies.
- Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration.
- 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.
- Provide local site intelligence to feasibility teams.
- Support site development.
What We're Looking For
- Bachelor’s degree or equivalent in life science, nursing, pharmacy, or medical laboratory technology.
- 12+ years of relevant clinical research experience within the pharmaceutical industry.
- Experience in leading and managing a professional team with strong experience in site management, monitoring, and overseeing large and/or complex global clinical trials.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
- Robust budget forecasting and management experience.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
- Proven experience in overseeing vendors and CROs.
- 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.
- Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.
Team & Environment
Leads both permanent and functional service-provider site management teams.
Work Mode
This is a remote position for candidates based in Europe.
Inclusion and Belonging is at the core of our mission. 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.
CSL is an Equal Opportunity Employer.
