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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. This role plays a pivotal role in building and managing meaningful productive relationships with KOLs and key investigator sites.
Job Responsibility:
Accountable for the strategic and operational oversight of investigational site management and monitoring activities across assigned clinical studies or programs
Ensure that clinical trials are executed with high quality, regulatory compliance, and operational efficiency
Partner with internal stakeholders and external service providers to develop and implement study-specific oversight plans, monitor site performance, and proactively identify and mitigate risks
Maintain sponsor oversight, validating the effectiveness of study and site-level activities
Ensure that monitoring plans and tools adequately address protocol-specific risks
Build and manage meaningful productive relationships with KOLs and key investigator sites
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
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
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
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.
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.