Clinical Trials Manager Jobs

Position: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 aClinical Trials Managerwho can work on a permanent full-time (hybrid) basis.

Qualifications:

• Knowledge of the clinical trial process. Knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements
• Advanced Microsoft Office Word, Excel and Power point programs knowledge and understanding
• 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
• 4 plus years of experience in clinical trial management
• Understanding of the regulatory progression of establishing and maintaining clinical sites
• 7 plus years’ experience in pharma and/or, biotech clinical research

Primary Responsibilities:

a.Management of trials and oversight of day-to-day trial operations (70%)

• 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
• Development and maintenance of enrollment plans including tracking enrollment, identifying trends, and implementing action plans to address issues in collaboration with study teams
• Track project progress and timelines and its adherence to the project plan
• Oversight and management of day-to-day trial operations including CRO management
• 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
• Creation and revision of SOPs as required
• Participate in the design and development of trial protocols, amendments and associated plans, manuals, CRFs and relevant trial materials
• Oversight and management of certain sub-studies that may be undertaken from time to time

b.Study Reports preparation and review (15%)

• Preparation and/or review of study reports for clinical sites (Newsletters, Enrollment Reports etc)
• Participate in the preparation of regulatory submissions related to assigned clinical trials
• Preparation and review of semi-annual progress reports/annual reports for the FDA and quarterly reports for the DSMB in conjunction with the CRO

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:

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

About Spectral Medical Inc

At Spectral Medical, we are pioneering a transformative theragnostic approach that will enable improved outcomes for patients withendotoxic septic shock (ESS).ESSis 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 Designationfor 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.