Global Clinical Development Director

4 weeks ago

Ottawa, Ontario, Canada TFS HealthScience Full time

About the Role

The Global Study Director (GSD) is a critical position within Study Management, 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.
  • 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.

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 expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.

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.

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