Manager, Clinical Trials AHRC
Providence Healthcare
St. Michael's Hospital, Toronto, Ontario, Canada
4d ago

RESPONSIBILITIES : Managerial

Managerial

  • Overall responsibility for all study project timelines and budgets
  • Overall responsibility for strategic project planning and risk management of all studies in the CTU
  • Responsible for recruiting, hiring, developing, mentoring, training, and conducting performance reviews of all direct reports, contract staff and students
  • Fiscally responsible for CTU operating budget
  • Responsible for developing and implementing policies, procedures and standards for the research program in line with ICH / GCP, regulations and hospital requirements
  • Negotiate terms of financing with outside parties (hospital and industry based)
  • Develop and negotiate research agreements and strategic alliances with outside parties
  • Develop budgets and approve allocation of funds for unfunded research projects presented to research program
  • Involved in the review of all confidentiality statements, legal disclosures, and legal documents with the Manager, Business Operations
  • Develop strategies for research network building
  • Research

  • Initiate and develop research proposals and RFP responses, as well as study protocols
  • Provide methodological and operational input to study protocols
  • Chair research group meetings
  • Participate in study Steering Committees
  • Participate in safety management, and quality assurance of research projects
  • Build and maintain relationships with academic and industry researchers and decision-makers, international academic clinical research organizations, and research network partner sites
  • Responsible for developing documentation and submitting proposals involving data linkages with external organizations (e.g. ICES, CIHI)
  • Administrative

  • Payroll approvals
  • Workload allocation
  • Develop and / or authorize research study budgets and payment schedules
  • QUALIFICATIONS :

  • At least a BSc in a health-related discipline; MSc preferred
  • 7 years of experience in clinical trial management
  • Strong knowledge of ICH / GCP and Health Canada regulations, as well as relevant privacy legislation (such as PIPEDA, PHIPA, US HIPAA) as it relates to the conduct of clinical research
  • Experience in human resource and financial management
  • Excellent interpersonal and communication skills
  • Superior customer service skills
  • Apply
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