Google Cloud PlatformGCPGoogle CloudProject ManagementCollaboration
About this role
Role Overview
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
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
This role will require travel to Investigator Meetings, Investigator sites and CROs. Anticipated travel >50%.
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
Requirements
Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology
10 years + clinical research experience within the pharmaceutical industry
Experience in leading / managing a team as well as in site management, monitoring and overseeing large and/or complex global clinical trials
Must have a strong understanding and experience in drug development process and specifically each step within the clinical trial process
Must have strong budget forecasting and management experience
Extensive experience and knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Experience / ability to 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.
Tech Stack
Google Cloud Platform
Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL