Global Study Associate Director

2 days ago

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

The Global Study Associate Director is a critical position within our Study Management team, responsible for delivering clinical studies. As a key member of our team, you will lead a cross-functional study team and provide guidance to ensure successful study delivery.

Key Responsibilities:
  • Lead and guide a cross-functional study team to ensure clinical studies progress as planned, meeting milestones, timelines, budget, and quality standards.
  • Facilitate communication across all functions, including external partners and service providers, and lead investigator meetings and other study-related meetings.
  • Ensure external service providers (CROs, central laboratories, IXRS, ePRO, etc.) are performing to contracted goals and timelines/budget, and adequate oversight is documented, with any issues escalated appropriately.
  • Develop and maintain relevant study plans, including required input into study-level quality and risk management planning, ensuring risk response strategies and issue escalation pathways are clear to the entire study team.
Qualifications:
  • University degree (or equivalent) in medical or biological sciences or a discipline associated with clinical research.
  • 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years of project management experience or equivalent combination of education, training, and experience.
  • Extensive knowledge of ICH-GCP clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development.
  • Demonstrated solid project management skills and knowledge of relevant tools, strong demonstrated abilities/skills in team leadership.
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:

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.

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.

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