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Global Study Director

2 months ago


Ottawa, Ontario, Canada TFS HealthScience Full time
Job Summary

We are seeking a highly experienced Global Study Director to join our team at TFS HealthScience. As a key member of our Study Management department, you will be responsible for the operational planning and delivery of high-priority and complex clinical studies.

Key Responsibilities
  • Operational planning and delivery of multiple studies or single, complex/novel studies to time, cost, and quality.
  • Contribution of expert clinical operational input into project strategy and study design.
  • Leadership and delegation of tasks to a cross-functional study team or oversight of outsourced delivery activities.
  • Ensuring the clinical study progresses as planned, driving achievement of milestones according to timelines, budget, and quality standards.
Requirements
  • University degree (or equivalent educational/work experience) in medical or biological sciences or a discipline associated with clinical research.
  • Minimum of 7 years progressive experience in clinical research, with at least 5 years of clinical development project management experience.
  • Extensive knowledge of ICH-GCP, relevant regulatory/ethics requirements, and clinical/drug development.
  • Thorough understanding of cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
  • Extensive and proven experience in project management and driving operational delivery to timelines, cost, and quality.
About TFS HealthScience

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making and foster a culture of mutual respect and collaboration.