Clinical Study Director

2 weeks ago

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

We are seeking an experienced Associate Director to join our Evidence Delivery team at TFS HealthScience. As a key member of our team, you will be responsible for the operational delivery of global strategic studies required to generate evidence to build confidence in company therapies.

Key Responsibilities:

  • Support and coordinate protocol development and finalization
  • Manage study governance and ensure compliance with regulatory requirements
  • Support and coordinate internal study governance processes
  • Manage external service providers and ensure high-quality delivery
  • Provide input into the selection of external service providers, including clinical research organizations
  • Support strategic handover meetings and kick-off meetings
  • Perform CRO oversight to ensure project delivery within time, cost, and quality
  • Support delivery of projects to agreed timelines (scorecard) within the approved budget and according to company quality standards
  • Support global oversight over the operational study start-up, implementation, and closure, ensuring inspection readiness

Qualifications:

  • Bachelor's degree in medical or biological science or equivalent by experience
  • Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process, and relevant guidelines (e.g., GCP/ICH) for a specific therapeutic and geographical area
  • Project management qualification or demonstration of project management skills, including scope, budget, timeline, resource management, and use of associated tools
  • Scientific awareness and extensive knowledge of observational study guidelines and SOPs

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 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. We have a strong presence in over 40 countries, with a team of over 800 professionals dedicated to delivering tailored clinical research services.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making and drive our commitment to excellence. We're a united force, working together to make a difference in the lives of patients.

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