Location: Canada [Remote/Hybrid]

Employment Type: Full-time

We are a non-profit biotechnology company focused on developing gene therapies for serious rare diseases with significant unmet medical need. We are seeking an organized, proactive Clinical Project Manager with clinical trial experience to join our growing team.

This role will be responsible for driving day-to-day clinical project activities across multiple studies and programs, working closely with internal team members, clinical sites, vendors, investigators, and external partners. The ideal candidate is comfortable working independently in a fast-paced environment, takes ownership of deliverables, and proactively identifies and escalates risks.

Please do not apply if you do not have clinical trial experience

No agencies please

Please provide salary expectations

Key Responsibilities

· Own and maintain clinical project timelines, deliverables, action items, risks, and dependencies across assigned studies.

· Coordinate cross-functional clinical trial activities and ensure deliverables remain on schedule.

· Lead routine project-management follow-up with internal team members, clinical sites, vendors, and external partners.

· Identify upcoming deadlines, risks, delays, and operational issues and proactively escalate items requiring attention or decision.

· Prepare and lead routine project status updates, including completed activities, upcoming milestones, overdue items, risks, and decisions needed.

· Coordinate study documentation, including study manuals, trackers, logs, training documentation, and other trial-management tools.

· Manage and maintain essential clinical and regulatory documentation, including financial disclosure documentation, study documents, and Trial Master File (TMF) records.

· Coordinate regulatory and Research Ethics Board (REB) submissions and maintain associated documentation.

· Support Health Canada clinical trial activities and documentation, as applicable.

· Coordinate study start-up, ongoing study management,



and closeout activities with sites and vendors.

· Manage study training documentation and ensure required training is completed and appropriately documented.

· Track vendor deliverables, timelines, outstanding actions, and performance.

· Monitor clinical data collection and work with data-management teams to support data quality, completeness, query resolution, and reconciliation.

· Review data-entry and data-cleaning status and escalate delays or outstanding issues.

· Assist with development and maintenance of data-management plans and study-specific data-management documentation, as applicable.

· Support audit and inspection readiness, including maintenance and review of essential project documentation.

· Develop and maintain project-management tools, templates, trackers, and processes to improve operational efficiency.

· Ensure activities are conducted in accordance with applicable regulations, ICH-GCP, company SOPs, and study-specific requirements.

Required Knowledge, Skills, And Abilities

· Strong knowledge of clinical research operations and Good Clinical Practice (GCP).

· Demonstrated ability to independently manage clinical project timelines, deliverables, risks, and competing priorities.

· Strong organizational and follow-through skills with excellent attention to detail.

· Ability to anticipate next steps and identify potential operational issues before they affect study timelines.

· Strong written and verbal communication skills.

· Ability to establish and maintain effective working relationships with cross-functional team members, investigators, clinical sites, vendors,



and external partners.

· Experience with clinical trial systems such as EDC, CTMS, eTMF, REDCap, Veeva, Medidata Rave, or similar platforms.

· Familiarity with clinical data-cleaning, query-resolution, and reconciliation workflows.

· Understanding of common clinical trial data, including laboratory data, adverse events/serious adverse events, demographics, patient-reported outcomes, and other clinical assessments.

· Knowledge of applicable clinical research regulations and guidance, including Health Canada requirements and ICH-GCP.

· Familiarity with Health Canada Clinical Trial Applications (CTAs), Research Ethics Board processes, and Canadian clinical trial requirements is strongly preferred.

· Ability to work independently and effectively in a small, fast-paced, evolving organization.

· Ability to adapt quickly to changing priorities and take ownership of projects with limited day-to-day supervision.

Qualifications

- Bachelor's degree in life sciences, public health, or a related field.
- 3-5 years of project coordination or project management experience in biotech, pharma, or a CRO.
- Experience supporting gene therapy or rare disease clinical trials is a plus.
- Familiarity with data management practices in clinical research (including EDC platforms)
- Prior experience managing small to mid-sized clinical projects or serving as a key support role on larger trials.
- Demonstrated ability to juggle multiple projects, prioritize tasks, and adapt to changing priorities.
- Experience with Canadian clinical trials and Health Canada requirements is preferred.

We are an equal opportunity employer and is committed to creating a diverse and inclusive work setting for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

📌 Clinical Project Manager - Gene Therapy Clinical Trials (Canada)
🏢 Elpida Therapeutics
📍 Canada