Trial Delivery Specialist - Clinical Trial Coordination

Roles & Responsibilities:
• Partner with Global Study Leaders to monitor study conduct, progress, risks, timelines, and budgets
• Support end-to-end operational study delivery from study set-up to close-out and archival
• Maintain and ensure completeness of study systems, trackers, databases, and project plans
• Review key clinical documents (Protocol, ICFs) and support development of monitoring, vendor, risk, and deviation management plans
• Coordinate cross-functional study team communication, meetings, and documentation
• Act as primary point of contact for country oversight activities including recruitment, data completeness, deviations, and local budgets
• Manage vendor and CRO oversight, ensuring delivery of study-specific deliverables
• Oversee clinical supplies, investigational products, and study materials; escalate supply risks proactively
• Ensure eTMF inspection readiness through setup, periodic review, and follow-up on missing or quality issues
• Support financial activities including change orders, expense tracking, and budget consistency across systems

Qualification:
• Bachelor’s degree in Life Sciences or related discipline

Experience:
• Relevant experience in clinical trial coordination, study operations, or global study delivery
• Experience working in FSP, CRO, or sponsor environments preferred

Skills:
• Strong knowledge of clinical trial operations and study lifecycle
• Experience with eTMF oversight, vendor/CRO management, and country coordination
• Good understanding of ICH-GCP and regulatory requirements
• Strong project management, risk management, and analytical skills
• Excellent communication, coordination, and stakeholder management skills
• Ability to work in a global, cross-functional environment

About the Organization:
The organization is a global biopharmaceutical leader advancing vaccines and innovative medicines, offering FSP professionals global exposure, end-to-end study ownership, and strong career growth opportunities in clinical research.