Global Clinical Study Director

2 days ago

Ottawa, Ontario, Canada TFS HealthScience Full time
Global Study Director

TFS HealthScience is a leading 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.

About the Role

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:

  • 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.
  • 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.

Qualifications:

  • University degree (or equivalent educational/work experience) preferably in medical or biological sciences or a discipline associated with clinical research.
  • Minimum of 7 years of 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, and 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.

A Bit More About Us

Our journey began over 27 years ago in Sweden in the city of Lund. As a full-service global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding lights, serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together, we make a difference.

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