Local Study Associate Director - Oncology - Canada - FSP
Remote · Ontario, Canada
Job Summary
Lead Local Study Team(s) at the country level to deliver committed components of clinical studies in line with resources, budget and timelines, ensuring compliance with ICH-GCP and local regulations. Oversee site identification, site qualification visits, initiation, monitoring, and archiving of essential documents; manage CTMS setup, site management, and risk mitigation. Coordinate cross-functional activities, support patient recruitment strategy, conduct local investigator meetings, manage budgets and drug supply, and ensure regulatory submissions and audits are handled in collaboration with local and global stakeholders. Essential skills include proven cross-functional leadership, project management, team building, organization, effective communication (English and local languages), negotiation, and adaptability to IT systems. Travel nationally and internationally as required. Education: Bachelor’s degree in life sciences or related field; minimum 3 years in development operations leading clinical trials in Canada; Oncology trial management experience; strong knowledge of ICH-GCP and local regulations.
Required Qualifications
- Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs)
- Minimum 3 years of experience in Development Operations leading clinical trials end to end in Canada in a CRO or Pharma organization
- Direct experience in Oncology clinical trial management
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations
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