Global Study Leader

Jazz Pharmaceuticals; Mississauga; On-site; CAD 120,000 - 160,000; Full time

Job summary

Jazz Pharmaceuticals is seeking an experienced Clinical Operations expert to lead and oversee global Phase I–IV clinical trials. The role requires strategic oversight, cross-functional leadership, and strong governance to ensure delivery on time and within budget.

You will mentor study managers and CRAs, drive trial planning, and maintain TMF integrity while ensuring adherence to ICH-GCP and regulatory standards. Domestic and international travel up to 20% is expected.

Qualifications

• 7+ years of clinical research with global trial management and portfolio oversight; leadership role experience.
• Excellent organizational, time-management, and attention to detail.
• Strong written and verbal communication and stakeholder management skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency with Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
• Experience with electronic systems like TMF and CTMS.
• Solid knowledge of regulatory requirements and ICH-GCP.
• Strong trial-process understanding and regulatory start-up planning.
• Proven cross-functional leadership and ability to influence senior levels.

Responsibilities

• Provide oversight to ensure study delivery and operational excellence.
• Lead implementation and management of global Phase I-IV trials.
• Lead trial-related meetings and coordinate cross-functional teams.
• Act as escalation point for stakeholders and ensure issue resolution.
• Develop and execute trial strategies with cross-functional teams.
• Maintain Trial Master File (TMF) and serve as SME for operations.
• Oversee trial documents, budgets, timelines, and vendor management.
• Coordinate IMP shipment approvals with regulatory and supply functions.
• Mentor GSMs, CRAs, and GSAs; lead CTWGs.

Skills

Clinical trial leadership

Cross-functional leadership

Project management

Regulatory knowledge

GCP compliance

Vendor management

Team mentorship

Communication skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

CTMS

TMF

MS Office

Job description

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.

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