Sr. Global Trial Lead

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The Global Trial Lead (GTL) provides strategic and operational oversight for global clinical trials, ensuring they are executed with excellence—on time, within budget, and in compliance with regulatory standards and internal policies. This role serves as a key leader within Global Development Operations (GDO), contributing to study-level strategy, cross-functional alignment, and issue and risk resolution. The individual guides trial execution across all phases and manages relationships with vendors to uphold performance and quality. This role may also lead global initiatives, support Operational Portfolio Leads on asset, trial and/or therapeutic-level inquiries, and influence decision-making at both study and organizational levels. The Global Trial Lead plays a pivotal part in driving delivery of registrational and non-registrational studies, with broad impact across therapeutic areas and global teams.

Key Responsibilities
Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:

Project Management

• Leads collaboration with internal study teams and vendors to ensure clinical trial delivery meets established timelines, budgets, and quality benchmarks.
• Provides strategic input on study feasibility and oversees operational activities of internal and external contributors.
• Identifies and proactively manages risks, balancing trade-offs between cost, deliverables, and quality.
• Manages scope of work (SOW) for CROs and Vendor Partners, ensuring alignment with contractual terms, budgetary targets, and quality standards.
• Participates in vendor selection and evaluation processes.
• Reviews, approves, and reconciles vendor invoices, accruals, and scope amendments.
• Utilizes performance metrics and quality indicators to monitor and optimize trial execution.
• Maintains and ensures accurate data records in study management systems such as Veeva (i.e. CTMS, eTMF, etc.)
• Develops and enforces trial-specific standards aligned with broader portfolio strategies to promote operational consistency.
• Leads development and execution of cross-functional and global best practices.
• Establishes and maintains study-level project management tools, including action logs, decision trackers, issue registers, and risk mitigation plans.
• Collaborates cross-functionally to ensure timely knowledge and information sharing.

Study Input & Strategic Guidance

• Offers therapeutic and operational guidance on study protocols and execution strategies.
• Provides consultation across programs/studies with a focus on risk mitigation and operational excellence.
• Monitors trends in clinical operations and advises teams on proactive responses.

Budgeting & Resource Planning

• Drives upfront planning of study timelines and budgets in partnership with cross-functional teams.
• Manages program-level vendor logistics and escalates resourcing needs appropriately.
• Identifies and resolves issues impacting budget and timeline adherence.
• Leads quarterly budget reviews, flagging anticipated variances for assigned trials and collaborating with Finance on forecasting.

Study Oversight

• Provides lifecycle leadership and oversight of assigned trial(s) from start-up to close-out phases.

Qualifications & Experience

Specific Knowledge, Skills, Abilities:

Technical Competencies

• Global Trial & Project Management : Leads global clinical trials with expertise in planning, execution, and oversigh