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Clinical Development Director

2 months ago

Ottawa, Ontario, Canada TFS HealthScience Full time

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.

The Global Study Director (GSD) is a business-critical role within Study Management, whose main accountability is the operational planning and delivery of high-priority and complex clinical studies or multiple studies within or across programs.

**Key Responsibilities:**

  • Operational planning and delivery of clinical studies to time, cost, and quality standards.
  • Leadership and delivery of multiple studies or overseeing single, complex/novel studies.
  • Contribution to project strategy and study design.
  • Operational interactions with external entities, including regulatory agencies and preferred partners/suppliers.
  • Study Management department leadership tasks as delegated by the Senior Director Study Management.
  • Leadership of a cross-functional study team or oversight of outsourced delivery activities.

**Requirements:**

  • 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.
  • Demonstrated abilities in clinical study management processes and clinical/drug development.
  • Thorough understanding of cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety, and regulatory affairs.

**Company Culture:**

TFS HealthScience is guided by core values of Trust, Quality, Passion, Flexibility, and Sustainability. These values serve as the framework for decision-making at all levels of the organization, fostering a unified force geared towards innovation and excellence.