Global Study Lead

Summary of Key Responsibilities

• Lead cross-functional trial teams to develop and execute study operational plans and deliver successful end-to-end trial execution.
• Accountable for trial-level delivery, including timelines, budget management, quality oversight, key milestones, and critical study deliverables.
• Oversee CRO and vendor selection, onboarding, contracting, budget management, performance monitoring, and issue resolution to ensure successful study delivery.
• Proactively identify operations risks and ensure that trial deliverables and milestones are met according to corporate and study-level goals.
• Identify risks and ensure mitigations and contingencies are being initiated and followed through.
• Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
• Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight
• Contribute to continuous improvement initiatives by identifying opportunities to enhance study execution, operational efficiency, quality, and cross-functional collaboration.
• Mentor and support onboarding and development of Study Management colleagues, sharing best practices and lessons learned across teams.
• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
• Prepare and provide operational updates, risks, and recommendations to governance forums, leadership teams, and cross-functional stakeholders.
• Ability to travel approximately 10% but flexibility to go over or below as per business need).

Qualifications