Clinical Study Director

15 hours ago

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

We are seeking a highly skilled Clinical Study Director to join our team at TFS HealthScience. As a Clinical Study Director, you will be responsible for the operational planning, delivery, and oversight of company-sponsored studies and externally sponsored studies, as well as Early Access Programs.

You will work closely with the scientific study leader, who is responsible for all scientific aspects throughout all stages of the study. This includes epidemiologists for observational studies and Medical Affairs Leaders for interventional studies.

Key Responsibilities
  • Provide insights on operational feasibility during the Study Design Concept development process.
  • Drive the process of coordinating protocol development by ensuring input from all relevant cross-functional (internal) and external stakeholders.
  • Provide input on operational feasibility of the protocol.
  • Coordinate all internal study governance processes, such as ERT, MARC, LSPC, and Clinical Challenge.
  • Lead the process for selecting External Service Providers (ESPs), including Clinical Research Organisations (CROs).
  • Set up study teams and manage study sourcing.
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, such as 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.
  • Extensive knowledge of early and late-stage Pharmaceutical Development.
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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