Global Senior Trial Delivery Manager – Sponsor Dedicated

Overview

In this role you lead the Study Management Team to coordinate global clinical trial management activities across insourced and outsourced studies. You ensure timelines, milestones, and inspection readiness while interfacing with internal and CRO/vendor stakeholders. You drive risk mitigation, CAPAs, and budget oversight, contributing to the successful delivery of trials from start-up to close-out. This position blends leadership, process improvement, and cross-functional collaboration to support global trial execution and compliance.

Responsibilities

• Lead the Study Management Team and provide trial-status updates to all team members
• Ensure timely, accurate trial documentation and real-time status reporting per trial plan
• Maintain constant inspection-readiness across SMT and related artifacts
• Serve as primary contact for country/regional staff and GCDO local teams
• Partner with Global Trial Lead to oversee central activities from planning to close-out
• Drive issue escalation and CAPA resolution, acting as CAPA owner when needed
• Support site selection feasibility and enrollment planning with data inputs
• Oversee budgets, country OOPs, and vendor spend; review vendor invoices
• Create/update trial-specific documentation (monitoring guidelines, ICF, IMP, etc.) and training materials
• Coordinate investigator meetings and maintain strong stakeholder relationships
• Ensure regulatory and SOP/GCP compliance and support HA/IRB submissions
• Provide input to cross-functional safety and escalation processes
• Contribute to data cleaning for timely database lock and oversee protocol-related knowledge

Key requirements

• BS degree in Life Sciences or equivalent
• 6–8 years of clinical trial management experience in pharma or CRO
• Strong knowledge of ICH-GCP and local regulations
• Proven leadership in building/high-performing global/regional teams
• Ability to coordinate virtual/global teams and manage multiple stakeholders
• Independent, complex decision-making and proactive risk management
• Experience with trial planning, start-up to database lock, and close-out
• Strong IT skills including CTMS, TMF, and Microsoft applications
• Travel willingness and business-language proficiency (local language + English)
• Experience in budgeting, vendor management, and CAPA processes

• strong leadership and delegation
• excellent communication and collaboration
• problem-solving and proactive risk mitigation
• Clinical Trial Management System (CTMS)
• Trial Master File (TMF)
• Document management and archiving

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