Clinical Trial Operations Lead

1 week ago


Toronto, Ontario, Canada Allucent Full time

About the Role:

We are seeking a highly skilled Senior Clinical Trial Leader to join our team at Allucent. As a key member of our organization, you will be responsible for providing leadership and management to our clinical research teams, ensuring the successful execution of clinical trials.

Key Responsibilities:

  • Lead and manage clinical research teams, including CRAs and other functional groups.
  • Coordinate and manage trial start-up, site activation, and monitoring activities.
  • Develop and implement trial plans, monitoring templates, and tools.
  • Manage critical documentation collection, maintenance, and filing.
  • Review trial-specific documents and develop subject-facing materials.
  • Customize annotated Site Visit Reports according to trial requirements.
  • Selection of investigators and sites; SEV report review and approval.
  • Site initiation management; SIV report review and approval
  • Monitoring Visit Report (MVR) review, management, resolution, and escalation.

Requirements:

  • Minimum 5 years clinical research experience, including CTL/CTM experience.
  • In-depth knowledge of ICH GCP, clinical trials, and critical elements for success.
  • Strong therapeutic background and experience in the CRO industry.
  • Excellent communication, leadership, and mentoring skills.
  • Ability to work in a fast-paced environment and manage multiple projects.

What We Offer:

  • Competitive salaries and comprehensive benefits package.
  • Departmental study/training budget for furthering professional development.
  • Flexible working hours and remote/hybrid work options.
  • Leadership and mentoring opportunities.
  • Internal growth opportunities and career progression.


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