Clinical Project Manager – Medical Device (Remote)

Overview

Perimeter Medical Imaging AI is a medical technology company driven to transform cancer surgery with its ultra-high resolution imaging technology to achieve our mission of advancing the standard of care, improving patient outcomes, and reducing healthcare costs. Our ultra-high-resolution, real-time, advanced imaging tools address areas of high unmet medical need.

With headquarters in Toronto, Canada and U.S. headquarters in Dallas, Texas, Perimeter Medical Imaging (TSXV:PINK)(FSE:4PC) has launched the next generation of imaging technology that allow surgeons to visualize microscopic tissue structures with unparalleled clarity in the operating room.

Job Description

We are hiring a Clinical Project Manager (CPM) III to join our Clinical Affairs team. The CPM III position will be responsible for the overall management and execution of the company’s clinical studies from site qualification to study close-out. In addition, the CPM will ensure that all clinical study project deliverables are completed on time and within budget and according to our SOPs, and all applicable regulatory requirements.

Responsibilities

• Manage and coordinate with cross-functional teams to support the company’s clinical and medical initiatives
• Manages the development of essential clinical study document SOPs, work instructions, and templates
• Serves as the clinical study expert in study meetings and compliancy audits

• Manages third-party vendors such as clinical research organizations (CROs)
• Manages and reviews the accuracy of all reports including monitoring reports and ensuring clinical study files are accurate, complete, and compliant
• Reviews and ensures that all essential study documents and device accountability records are accurate and stored appropriately in the TMF
• Investigates and resolves all data discrepancies in a timely manner

• Drives the discovery process for vetting new clinical study software tools and technologies
• Strong working knowledge of FDA regulations and GCP compliance
• Ensures that all study staff are appropriately trained and prepared to conduct the clinical study in accordance with the IRB approved protocol and applicable regulations
• Ensures any identified non-compliance issues are addressed, clearly communicated, appropriately documented, and escalated as warranted

• Manage clinical studies according to the timeline and budget
• Prepare and present project information at internal and external meetings
• Develop clinical study timelines and operational budgets
• Develop and use tools to track the overall study KPIs and manage all study activities to ensure on-time delivery
• Reports study performance and timelines to senior management
• Ensures eTMF maintenance in accordance with regulatory standards and requirements
• Develop project plans, timelines and status reports, and communicate with all applicable team members internally and externally

Minimum Qualifications

• Bachelor’s degree in Medical or Biology related major required
• Minimum of 5 years of previous clinical research experience required
• Minimum of 5 years of previous project management experience required
• Previous experience managing people required
• Medical Device industry experience and previous experience with oncology (solid tumor) preferred
• Previous experience developing training material, giving presentations, analyzing clinical study data and identifying trends
• Effective at time management and able to work independently
• Proficiency with Microsoft Word, Excel, and PowerPoint
• Ability to successfully manage competing priorities and adapt quickly to changing priorities

Additional Skills and General Expectations

• Excellent presentation and facilitation skills
• Ability to travel up to 40%
• Has a valid driver’s license

Does this look like a good fit for you?
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To apply for this role, please email us your resume and (optional) cover letter with “Clinical Project Manager – Medical Device” in the subject line to: careers@perimetermed.com

Perimeter Medical AI is committed to your success and providing opportunities for career and professional advancement. We maintain a fun and outgoing, yet professional environment that truly values our employees. As a part of our commitment to inclusivity, diversity, equity and accessibility, our goal is a workforce built on respect that reflects the communities we serve. We thank all applicants for their interest in Perimeter Medical AI but only those selected for an interview will be contacted.

Perimeter Medical Imaging AI is an equal opportunity employer and supports workforce diversity. Perimeter welcomes and encourages applications from people with disabilities. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

We are proud to be in compliance with the Accessibility for Ontarians with Disabilities Act (AODA), 2005 and the Integrated Accessibility Standards Regulation. We are happy to honor accommodations at any part of the recruitment process and invite you to let us know how we can help.