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 explicit 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.

📌 Global Study Leader (Mississauga)
🏢 Jazz Pharmaceuticals
📍 Mississauga