Global Study Leader

Essential Functions/Responsibilities

• In partnership with the study team and internal and external service providers, provides oversight to ensure study delivery and ensure operational excellence.
• Delegate tasks to study team members as appropriate.
• Lead implementation, execution and management of global Phase I-IV clinical trials.
• Lead, facilitate and delegate trial-related meetings, ensuring alignment with cross-functional teams.
• Act as a primary point of escalation for cross-functional stakeholders for timely issue resolution and alignment.
• Participate in program-level discussions (FMT, GPT), providing clear and timely updates to senior management (as needed).
• Develop and execute clinical trial strategies in collaboration with cross-functional teams during the trial lifecycle including tracking and reporting trial progress, risks and mitigation strategies to senior leadership.
• Hold overall accountability for the Trial Master File (TMF). Acts 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) in line with Standard Operating Procedures (SOPs).
• Actively contribute to the operational oversight and strategic direction of assigned studies, including feasibility assessments, planning, vendor selection, patient recruitment strategies, and financial forecasting.
• Contribute to the planning and conduct of Investigator Meetings, including driving meeting preparation, presenting trial materials, and supporting effective delivery of key messages.
• Identify, assess, and proactively manage risk and contingencies to safeguard timelines, quality and compliance.
• Develop, manage and track trial timelines and budgets, in line with projected spend. Estimate, track and critically analyze vendor financial spend on trials.
• Accountable for the oversight and management of external service providers and vendors to ensure quality, compliance, and performance.
• Oversee trial tracking activities and ensure accurate, timely updates within trial management systems.
• Accountable for final approval and oversight of trial documentation archiving in compliance with regulatory and company requirements.
• Serve as trial lead and SME during audits and inspections.
• Coordinate Investigational Medicinal Product (IMP) shipment authorization with regulatory and clinical supplies functions.
• Assist and support data query process.
• Perform monitoring visit report review (as required).
• Lead and participate in Clinical Operations / Global Clinical Development Operations (GCDO) initiatives (as assigned).
• Serves as a Clinical Operations SME in the design and review of processes.
• Ensure trial activities are conducted according to GCP and relevant SOPs and in accordance with the agreed timelines and trial protocol.
• Leadership / People Management Responsibilities:
• Mentor and coach Global Study Managers (GSMs), Clinical Research Associates (CRAs), and Global Study Associates (GSAs) to support professional development.
• Lead Clinical Trial Working Groups (CTWG)s.
• 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 proven global trial management and portfolio-level oversight with a 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 both independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Experience with and strong knowledge of Clinical Trial electronic systems (e.g., TMF, Clinical Trial Management System (CTMS), etc.).
• Strong knowledge of clinical trial processes, ICH-GCP, and regulatory requirements.
• Strong knowledge of regulatory start up process and planning in support of Study Start-Up (SSU).
• Proven track record of effectively managing in a cross-functional environment.
• Excellent project management skills with a proven track record of managing global, multi-center clinical trials.
• Strong leadership and governance experience; ability to influence at senior levels.
• 10% to 20%Domestic and International travel

Required/Preferred Education and Licenses

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