Clinical Study Director

3 days ago

Ottawa, Ontario, Canada TFS HealthScience Full time
About the Role

The Global Study Director is a critical position within our Study Management team, responsible for the operational planning and delivery of high-priority and complex clinical studies or multiple studies within or across programs.

This role requires a strong understanding of clinical research and development, as well as excellent leadership and project management skills. The successful candidate will be responsible for leading a cross-functional study team, collaborating with external entities, and driving the achievement of milestones according to timelines, budget, and quality standards.

Key Responsibilities
  • Operational planning and leadership of multiple studies or complex/novel studies to time, cost, and quality.
  • Contribution of expert clinical operational input into project strategy and study design.
  • Collaboration with external entities, including regulatory agencies, preferred partners, and suppliers.
  • Leadership of study management department tasks, as delegated by the Senior Director Study Management.
  • Leadership and facilitation of communication across all functions, and collaboration with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams.
Qualifications
  • University degree 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 Us

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

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