​​Global Study Leader​

About the Role

In partnership with the study team and internal and external service providers, provides oversight to ensure study delivery and operational excellence. Lead implementation, execution, and management of global Phase I–IV clinical trials, acting as a primary point of escalation for cross-functional stakeholders.

Responsibilities

• Delegate tasks to study team members as appropriate.
• Lead, facilitate, and delegate trial-related meetings, ensuring alignment with cross-functional teams.
• Participate in program-level discussions, providing clear and timely updates to senior management.
• Develop and execute clinical trial strategies, including tracking and reporting trial progress, risks, and mitigation strategies.
• Hold overall accountability for the Trial Master File (TMF) and act as an SME for Clinical Operations related sections.
• Lead the development and review of trial-specific plans and essential clinical trial documents.
• Review and approve key trial documents, including protocols, informed consent forms, monitoring plans, and Clinical Study Reports (CSRs).
• Contribute to operational oversight and strategic direction, including feasibility assessments, vendor selection, patient recruitment strategies, and financial forecasting.
• Identify, assess, and proactively manage risk to safeguard timelines, quality, and compliance.
• Develop, manage, and track trial timelines and budgets.
• Estimate, track, and analyze vendor financial spend on trials.
• Oversee external service providers and vendors to ensure quality, compliance, and performance.
• Ensure accurate and timely updates within trial management systems.
• Coordinate Investigational Medicinal Product (IMP) shipment authorization.
• Assist in the data query process and perform monitoring visit report review as required.
• Lead and participate in Clinical Operations / Global Clinical Development Operations (GCDO) initiatives.
• Ensure trial activities comply with GCP, SOPs, and agreed timelines.

Leadership / People Management Responsibilities

• Mentor and coach Global Study Managers (GSMs), Clinical Research Associates (CRAs), and Global Study Associates (GSAs).
• Lead Clinical Trial Working Groups (CTWGs).
• Provide leadership in resolving complex trial issues and escalating risks appropriately.
• Manage and maintain high-performing clinical teams.

Required Knowledge, Skills, and Abilities

• 7+ years of clinical research experience, with global trial management and portfolio-level oversight.
• Minimum of 3 years in clinical operations leadership roles.
• Excellent organizational skills, time management, and attention to detail.
• Excellent written and verbal communication skills and stakeholder management abilities.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Experience with Clinical Trial electronic systems (e.g., TMF, CTMS).
• Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements.
• Proven track record of managing global, multi-center clinical trials.
• Strong leadership and governance experience; ability to influence at senior levels.

Education

Bachelor’s degree, preferably in life sciences, healthcare, or a related field, or equivalent experience. Advanced degree preferred.

Travel

10% to 20% travel required.

Pay

The full and complete base pay range for this role is: $140,000.00 - $210,000.00. Individual compensation will depend on factors such as qualifications, skills, experience, and job knowledge.