Lead Clinical Site Ambassador (Remote)

Position Description and Summary

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

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 needes

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

• 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.