Clinical project manager sénior

3 weeks ago

Ontario, Canada Spectral Medical Inc. Full time

Clinical Trials Manager
Site: Spectral Medical Inc.
Permanent Full-Time (Hybrid)
Spectral Medical Inc. is looking for a Senior Clinical Trials Manager who can work on a permanent full-time (hybrid) basis.
7 plus years’ experience in pharma and/or, biotech clinical research
~4 plus years of experience in clinical trial management
~ Experience with FDA regulatory submissions is a preferred skill
~ CCRP or equivalent is an asset
~ Experience in critical care studies and renal studies is an asset
~ Demonstrated success in managing clinical projects from initiation to close out
~ Knowledge of the clinical trial process. Knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements
~ Understanding of the regulatory progression of establishing and maintaining clinical sites
~ Advanced Microsoft Office Word, Excel and Power point programs knowledge and understanding

Management of trials and oversight of day-to-day trial operations (60%)
Track project progress and timelines and its adherence to the project plan
Oversight and management of day-to-day trial operations including CRO management
Oversight and management of certain sub-studies that may be undertaken from time to time
Participate in the evaluation of potential clinical study sites and management of site start-up, close-out and maintenance activities, and scheduling of monitoring visits in accordance with data collection timelines
Coordinate site trainings, shipment of study supplies, and review of regulatory documents for the release of investigational products to site
Track study budgets, reconcile payments, and escalate any issues to ensure accurate and timely payments to trial sites and vendors in line with contracts
Oversee study monitoring including reviewing finalized monitoring reports generated by CRO to track site level activities and identify issues, trends, etc
Preparation and/or review of study reports for clinical sites (Newsletters, Enrollment Reports etc)
Preparation and review of regulatory submissions related to assigned clinical trials (this includes FDA communications, FDA Clinical Study Reports, PMA related submissions, etc)
Management of Study Team Members (15%)
~ Oversee study team members performance and training, delegate tasks and support their roles as necessary

Hybrid remote work flexibility
About Spectral Medical Inc
At Spectral Medical, we are pioneering a transformative theragnostic approach that will enable improved outcomes for patients with endotoxic septic shock (ESS). EAA and PMX are both Health Canada licensed and commercially available in Canada. Spectral strives to exceed the highest ethical, financial and scientific standards in all our operations and activities. By maintaining excellent relationships within the clinical community, as well as with customers and business partners. Spectral Medical Inc values the diversity of people and actively encourage women, indigenous peoples, members of visible minorities, people with disabilities, and LGBTQ2+ persons to apply. Job Type: Permanent
Dental care
Extended health care
Flexible schedule
On-site parking
Flexible Language Requirement:
~ French not required

Monday to Friday

Pharma/Biotech Clinical Research: 7 years (required)
Clinical Trial Management: 4 years (required)
FDA Regulatory Submissions: 2 years (required)
Work Location: Hybrid remote in Etobicoke, ON M9C 1C2

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