Clinical Trial Assistant – Phase I à IV

Job summary

• Manage and maintain the Trial Master File (TMF) and ensure quality control, ensuring the completeness, accuracy, and compliance of study documentation; • Track and manage essential study and site-related documents;

Job details

Clinical Trial Assistant – Phase I à IV Position open only to Canadian citizen\resident or with Canadian work permit Full Time ________________________________________ Seriant, a division of the Montreal Heart Institute, is a clinical research organization that provides comprehensive services to the pharmaceutical and biotechnology industries, as well as to the academic community. Based in Montreal, we operate internationally, covering all phases of clinical trials across a wide range of therapeutic areas. With our proven expertise in developing innovative therapies, we make a meaningful impact on people’s lives around the world. We believe that great minds change the world. We’re looking for passionate individuals to help manage and support clinical studies that improve healthcare and create lasting impact. Just as we transform lives through research, we enrich the lives of our employees with benefits that truly make a difference. Your contribution matters, your growth is valued, and your impact is real. Join us and put your skills in the spotlight.

What you’ll do

RESPONSABILITIES • Manage and maintain the Trial Master File (TMF) and ensure quality control, ensuring the completeness, accuracy, and compliance of study documentation; • Track and manage essential study and site-related documents; • Support study start-up, conduct, and close-out activities for clinical trials; • Maintain up-to-date information and tracking tools within CTMS and eTMF systems, and generate required reports; • Coordinate study documentation with sites, vendors, and internal teams, including the tracking of study documents and study materials; • Coordinate team meetings, prepare agendas and meeting minutes, and follow up on action items; • Support audit and inspection readiness activities, as well as document reconciliation and verification processes; • Ensure proper archiving and retention of study documentation in accordance with regulatory requirements and internal procedures; • Contribute to the continuous improvement of study processes, tools, and tracking systems; • Organize and assist with the activities of various clinical study meetings and/or committees; • Provide administrative and office support to the study team and the organization, as required.

Requirements

REQUIREMENTS • Bachelor’s degree in life sciences or related field preferred. (Mandatory) • Perfectly bilingual spoken and written French / English (Mandatory & Tests to pass) • Relevant experience (2 years) in the pharmaceutical, biotechnology industry or in a contract research organization (an asset); • Previous experience in clinical research or clinical trial administration • Experience with eTMF and CTMS SKILLS • Strong organizational skills and attention to detail • Ability to manage multiple tasks and timelines in a fast-paced environment. • Strong written and verbal communication skills. • Ability to work effectively with minimum supervision. • The person selected must be proactive, autonomous, creative and a "team player" KNOWLEDGE • Working knowledge of clinical research and the pharmaceutical industry as well as the • ICH/GCP guidelines would be an asset • Skills of the MS Office suite (Word, Excel, and PowerPoint) intermediate level (Tests to pass for Word & Excel)

Benefits

WORK CONDITIONS • 35 hours weekly base • Pre-approved overtime paid • Flexible work schedule for work-family balance • Hybrid model • 4 weeks’ vacation after one year • 13 statutory holidays • Defined retirement benefits (RREGOP) • Group insurance • 9.6 day off sick days We offer a wide range of benefits aimed at the health, well-being, and quality of work life of employees, including free access to the EPIC Center, as well as various other benefits. TO SUBMIT YOUR APPLICATION : • Deadline to apply: 16 Octobre 2026 • Please attach your cover letter and resume and send to: Lien ATLAS We subscribe to an equal access program. Applications from targeted groups (women, visible minorities, ethnic minorities, Indigenous peoples, and persons with disabilities) are encouraged We thank all those who apply to this position but only candidates that have been selected for an interview will be contacted. Visit our web site: www.seriant.org

Listed skills

• Organization · Preferred
• Attention to detail · Preferred