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Global Study Director

2 months ago


Ottawa, Ontario, Canada TFS HealthScience Full time

About the Role

The Global Study Director is a key position within our Study Management team at TFS HealthScience, a leading global Contract Research Organization (CRO). This role is responsible for the operational planning and delivery of high-priority and complex clinical studies or multiple studies within or across programs.

Key Responsibilities:

  • Accountable for the operational planning, leadership, and delivery of multiple studies or overseeing single, complex/novel studies to time, cost, and quality.
  • Contributes expert clinical operational input into project strategy and study design/documents.
  • May contribute to operational interactions with external entities, including regulatory agencies, preferred partners/suppliers, and external collaborators.
  • May perform Study Management department leadership tasks as delegated by the Senior Director Study Management.
  • Leads, provides guidance, and delegates appropriately to a cross-functional study team or oversees outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget, and quality standards.
  • May hold accountability and/or oversight of several studies.
  • Leads and facilitates communication across all functions. Collaborates with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams.

Requirements:

  • University degree (or equivalent educational/work experience), preferably 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 (or equivalent).
  • Extensive knowledge of ICH-GCP, relevant regulatory/ethics requirements, and clinical/drug development, with 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.
  • Extensive and proven experience in project management and driving operational delivery to timelines, cost, and quality.

What We Offer

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.

About TFS HealthScience

TFS HealthScience is a full-service, global 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 build solution-driven teams working towards a healthier future, bringing together over 800 professionals in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making and foster a culture of mutual respect and collaboration. We cultivate a unified force, geared towards innovation and excellence, and strive to make a difference in the lives of patients.