Feldan Therapeutics, a biotech company specializing in the development of intracellular delivery-based therapeutics, is seeking a Clinical Trial Assistant to join its dynamic team. The Clinical Trial Assistant (CTA) provides essential operational and administrative support to the clinical operations team to ensure the efficient, compliant, and timely execution of clinical studies. The CTA reports to the VP of Clinical Development and works closely with Clinical Study Managers (CSMs), Associate CSMs, vendors, and internal cross-functional teams to maintain study documentation, support study tracking, and ensure readiness for audits and inspections in accordance with ICH-GCP and applicable regulatory requirements.
This role serves as a key contributor to study start-up, conduct, and close-out activities.
This role serves as a key contributor to study start-up, conduct, and close-out activities.
| Key Responsibilities |
- Provide day-to-day operational and administrative support to assigned clinical studies across their lifecycle (start-up, conduct, close-out).
- Support coordination with CROs, vendors, and external partners under the direction of Clinical Operations leadership.
- Organize and support internal and external study meetings, including scheduling and preparation of agendas, minutes, and action-item tracking.
- Prepare, file, and maintain accurate and complete clinical trial documentation, including Trial Master Files (electronic and/or paper).
- Perform periodic TMF quality checks to ensure inspection readiness and compliance with GCP and company SOPs.
- Support document distribution, version control, and archival activities in accordance with Good Documentation Practices (GDocP).
- Develop and maintain study trackers, spreadsheets, and filing systems to support timelines, deliverables, and study oversight.
- Track study action items, milestones, and deliverables, escalating issues to Clinical Operations leadership as appropriate.
- Assist with the review and tracking of monitoring follow-up items, deviations, and site communications (without assuming monitoring authority).
- Contribute to audit and inspection readiness activities throughout the study lifecycle.
- Support risk identification and mitigation tracking under guidance from Clinical Operations leadership.
- Ensure strict adherence to ICH-GCP, applicable regulatory requirements (FDA, EMA), and internal SOPs.
- Support tracking of study budgets, forecasts, and invoices in collaboration with Clinical Operations and Finance teams.
- Assist with vendor invoice reconciliation and documentation tracking as required.
- Performs other tasks as assigned by line manager, that support the company's objectives;
- Strict observance of Good Documentation Practices and Standard Operating Procedures (SOPs) in force within the company & applicable to the position.
| Qualifications and Requirements |
Required
- Bachelor’s degree or college diploma in life sciences, health sciences, or a related field.
- Foundational knowledge of clinical trial processes and Good Clinical Practice (ICH-GCP).
- Strong organizational skills and attention to detail.
- Ability to work independently and collaboratively in a cross-functional team environment.
- Proficiency with Microsoft Office tools (Excel, PowerPoint, Word); familiarity with study tracking tools preferred.
- Bilingual (French and English), written and spoken. French is the usual language used to communicate with employees and manage internal operations. English is essential for interactions with partners and investors in different countries
Preferred / Asset
- Previous experience in clinical research, pharmaceutical industry, or CRO environment.
- Experience with eTMF systems, CTMS, or other clinical trial platforms.
- Exposure to CRO-managed studies or multi-site clinical trials.
| Desired Skills |
- Excellent organizational and time‑management skills
- Clear written and verbal communication
- Effectively balances multiple priorities while maintaining compliance and quality standards in a regulated environment
- Strong interpersonal and collaboration skills
- Analytical mindset and problem-solving ability
- Adaptability and resilience in a dynamic clinical development setting
| Offered Benefits |
- 37.5-hour workweek, day shift
- Flexible schedule between 6:00 AM and 6:00 PM
- Optional remote work two days a week
- Group insurance (Health, dental, medication)
- Employee assistance program
- Telemedicine
- Group RRSP
- Fonds de solidarité FTQ RRSP
- Eligibility for annual bonus
- Vacation and wellness days
- Work-life balance
- Positive work culture focused on collaboration, fun, innovation, and excellence
- Social activities
- Bright and spacious work environment
- Childcare (CPE) service reserved for employees of the nearby technology park
- On-site parking
Those interested are invited to submit their application to Catherine Lippé (clippe@feldan.com).