Clinical Trial Operations Manager

4 weeks ago

Toronto, Ontario, Canada Allucent Full time
Job Description

We are seeking a highly skilled and experienced Clinical Trial Operations Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial activities.

Key Responsibilities:

  • Coordinating and managing CRA activities across all geographies, liaising with sponsors and project managers to ensure clinical monitoring deliverables are met.
  • Oversight of critical documentation collection, maintenance, and filing.
  • Developing monitoring plans and site monitoring templates and tools.
  • Reviewing trial-specific documents and developing subject-facing materials.
  • Customizing annotated site visit reports according to trial-specific requirements.
  • Selection of investigators and sites, SEV report review, and approval.
  • Site initiation management, SIV report review, and approval.
  • Monitoring visit report review, management, resolution, and escalation.
  • Managing successful trial close-out, identifying critical activities to make timely and efficient close-out.
  • Responsible for timelines, budget, and quality of clinical monitoring team deliverables.

Requirements:

  • A degree in life sciences or nursing qualification preferred, but not required.
  • A minimum of 5 years clinical research experience, including a combination of SCRA + CTL/CTM, PM, or regulatory/auditing experience.
  • In-depth knowledge of ICH GCP, clinical trials, and critical elements for success in clinical trials.
  • Strong therapeutic background.
  • Possesses experience and knowledge in the CRO industry that will support Allucent's management of clinical trials.

Benefits:

  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental study/training budget for furthering professional development.
  • Flexible working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.

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