Global Trial Lead (multiple openings)

1. Project Management

• Holds singular operational accountability for medical study delivery, partnering closely with the MEG Lead and internal study teams to ensure execution meets established timelines, budgets, and quality benchmarks
• Directly oversees all operational activities of internal and external contributors — with no delegation of primary operational accountability to a CRO or external party
• Identifies and proactively manages risks, balancing trade-offs between cost, deliverables, and quality
• Owns and manages the 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 study execution
• Ensures accurate data records in study management systems such as Veeva (i.e. CTMS, eTMF, etc.)
• Develops and enforces study-specific operational standards aligned with broader portfolio strategies to promote 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

2. Study Input & Operational Guidance

• Offers operational guidance on study execution strategies, working in close alignment with the MEG Lead on protocol design and clinical/medical oversight matters
• Provides consultation across programs/studies with a focus on risk mitigation and operational excellence
• Monitors trends in medical and clinical operations and advises teams on proactive responses

3. Budgeting & Resource Planning

• Owns upfront planning of study timelines and budgets in partnership with cross-functional teams
• Directly manages all study-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 studies and collaborating with Finance on forecasting

4. Study Oversight

• Bears full lifecycle operational accountability for assigned study/studies from start-up through close-out phases, with no split or shared ownership of operational outcomes
• Acts as the primary point of escalation for all study operational matters within MEG Operations, escalating clinical and medical questions to the MEG Lead as appropriate
• Works closely with MEG Operations, MEG, and cross-functional teams to ensure administrative tasks are appropriately executed upon (e.g., eTMF document upload and periodic reviews, CTMS maintenance, finance reconciliation and hygiene)

Technical Competencies

• Medical Study & Project Management Leads global medical studies with expertise in planning, execution, and full operational ownership. Ensures regulatory compliance, patient safety, and timely delivery of high-quality data. Drives study outcomes through operational coordination and progress tracking, in close partnership with the MEG Lead.
• Operational & Budget Oversight Manages end-to-end study operations, including site selection, recruitment, vendor coordination, and resource planning. Oversees budgets, forecasts, accruals, and cost optimization to ensure financial accuracy and efficiency.
• Risk & Quality Management Identifies and mitigates operational risks to ensure study continuity. Maintains GCP/GXP compliance and supports audit readiness with a strong quality mindset.
• Stakeholder & Vendor Engagement Builds strong relationships with internal and external stakeholders, including the MEG Lead and cross-functional partners. Manages communications, escalations, and alignment across functions and geographies.
• Clinical & Regulatory Expertise Demonstrates knowledge of clinical trial phases, therapeutic areas, and regulatory requirements. Ensures operational readiness for submissions and compliance with global standards.
• Systems & Data Management Utilizes CTMS and other clinical/medical systems to track milestones, ensure data quality, and support decision-making. Partners with technical teams to maintain system integrity.

Management Competencies

• Leadership & Collaboration Drives cross-functional teams toward shared goals while maintaining clear personal accountability for all study operational outcomes. Builds consensus and fosters an inclusive, high-performing culture through strong partnership, including with the MEG Lead.
• Critical Thinking & Decision Making Solves complex operational problems and makes timely, informed decisions that prioritize patient safety and data integrity.
• Accountability & Results Focus Fully owns all study operational outcomes, ensures quality, and delivers on time and within budget through proactive, hands-on oversight.
• Adaptability & Resilience Responds effectively to change and manages conflict constructively while maintaining team morale.
• Communication & Relationship Building Communicates clearly across global teams and builds strong, trust-based relationships with diverse stakeholders.

Education/Experience/Licenses/Certifications

• BA/BS or equivalent degree in relevant discipline.
• Minimum 4 years of experience in clinical/medical operations roles and project management in the pharmaceutical or healthcare industry, including multi-national experience.
• Experience in leading global clinical/medical trials with strong project management/organizational skills and presentation and communication abilities.
• Experience leading global and multi-functional teams in a matrixed environment.
• Experience in managing CROs, preferred.
• Travel requirement: up to 25%.