Senior Clinical Trials Manager

Found in: Whatjobs CA C2 - 2 weeks ago

Etobicoke, Canada Spectral Medical Inc. Full time

Position: Sr.  Clinical Trials Manager

Site:  Spectral Medical Inc.

Department:  Clinical Operations

Reports to:  VP, Clinical Operations

Hours:  37.5 per week

Status:  Permanent Full-Time

Spectral Medical Inc. is looking for a Senior Clinical Trials Manager who can work on a permanent full-time (hybrid) basis. 

 

Qualifications:

  • 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

 

Primary Responsibilities:

a.       Management of trials and oversight of day-to-day trial operations (60%)

  • Participate in the design and development of trial protocols, amendments and associated plans, manuals, CRFs and relevant trial materials
  • 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
  • Development and maintenance of enrollment plans including tracking enrollment, identifying trends, and implementing action plans to address issues in collaboration with study teams
  • 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
  • Creation and revision of SOPs as required

 

b.      Study Reports preparation and review (25%)

  • Preparation and review of semi-annual progress reports/annual reports for the FDA and quarterly reports for the DSMB in conjunction with the CRO
  • 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)

 

c.        Management of Study Team Members (15%)

  • Oversee study team members performance and training, delegate tasks and support their roles as necessary


 WHAT WE OFFER:

  • Great learning and growth opportunities
  • Hybrid remote work flexibility
  • A competitive compensation package
  • Full Benefits Package

 

 

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). ESS  is a life-threatening condition that arises when the body’s response to infection spirals into a storm of systemic inflammation. It’s characterized by a dangerous drop in blood pressure and a cascade of multiple organ failure caused by the presence of a bacterial toxin, known as endotoxin.

 

Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with endotoxic septic shock, Polymyxin B hemoadsorption (“PMX”). PMX is a therapeutic hemoadsorption device that removes endotoxin from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA-cleared diagnostic for endotoxin in the bloodstream.

 

EAA™ and PMX are both Health Canada licensed and commercially available in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation  for PMX for the treatment of endotoxic septic shock.

 

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. Leading with precision and innovation, Spectral is unwavering in the fight against endotoxic septic shock and is committed to reducing mortality from this deadly disease.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT.


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. We thank all applicants in advance, however, only those selected for an interview will be contacted.


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