Clinical Trial Associate 1 or 2

Xenon Pharmaceuticals; Vancouver; Hybrid; CAD 65,000 - 90,000; Full time

Benefits offered by this job

Base salary

Target bonus

Stock options

Medical

Dental

Vision

Disability insurance

Life insurance

Employee Assistance Program

Travel insurance

Retirement savings with company match

Vacation

Personal days

Sick days

End-of-year shutdown

Training & Development

Job summary

Xenon Pharmaceuticals is seeking a Clinical Trial Associate 1 or 2 to support Clinical Operations in conducting clinical trials. This role collaborates with study teams, CROs and sites to ensure compliant, timely trial activities and documentation.

The position is based in Vancouver, BC with a hybrid work model requiring at least two days on-site weekly. The candidate will assist with study materials, trial master files, vendor coordination, and budget tracking, contributing to efficient trial

Qualifications

• Bachelor’s degree in health sciences or related field is required.
• Excellent written and verbal communication and strong organizational skills are required.
• Experience with clinical trials and ICH-GCP guidelines is preferred? (per the responsibilities)

Responsibilities

• Review clinical documents and participate in start-up activities.
• Track regulatory documents for site activation and consent forms.
• Develop and update trial tracking tools for recruitment, supplies and documentation.
• Maintain eTMF and oversee CRO eTMF quality.
• Collaborate with CROs, vendors and sites on trial activities and sample management.
• Process approved invoices and payments to vendors and sites.
• Assist with meeting logistics and documentation for study teams.
• Prepare shipment requests and reports for trial management.
• Monitor timelines, budgets and trial materials.
• Assist Investigator meetings planning and preparation.
• Support due diligence, audits and regulatory inspections.

Skills

Project management

Communication

Organizational skills

Education

Bachelor’s degree in health sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Who We Are:

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

What We Do:

We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy, depression and pain. Our Phase 3 azetukalner program represents the most advanced, clinically validated potassium channel modulator in late-stage clinical development for multiple indications. In March 2026, we announced positive topline data from our Phase 3 X-TOLE2 study of azetukalner in focal onset seizures (FOS), and we anticipate submitting a New Drug Application to the Food and Drug Administration in the third quarter of 2026. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. We also have multiple Phase 3 azetukalner clinical trials underway in major depressive disorder (MDD) and bipolar depression (BPD), based on topline data from our Phase 2 X-NOVA clinical trial. In addition, we are proud of our strong heritage in human genetics, deep understanding of ion channel biology, and expertise in novel chemistries to enable potent, selective ion channel targeting. We continue to advance an early-stage pipeline of novel therapeutic candidates, including Phase 1 studies for XEN1701 and XEN1720 (targeting Nav1.7) and XEN1120 (targeting Kv7), which are being developed for pain. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.

About the Role:

We are seeking a Clinical Trial Associate 1 or 2 to join our team. The Clinical Trial Associate 1 or 2 will be an individual responsible for supporting Clinical Operations team members with project-specific support related to the conduct of clinical trials activities. The Clinical Trial Associate 1 or 2 will assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administrative and project tracking support.

This position reports to the Director, Trial Operations, and will be based out of our Vancouver, BC office. The level of the position will be commensurate with the candidate’s education and industry experience. This is a Hybrid position requiring a minimum of two onsite days per week.

RESPONSIBILITIES:

• Work with the clinical operations team in review of clinical documents (Protocols, Informed Consents, study plans and related documents). Participate in study start up activities including preparation and maintenance of study reference manuals, site tools, templates, source documents and guidelines.

• Assist with the review and tracking of key regulatory documents required for site activation, including the tracking and review of site/country specific informed consent forms.

• Develop and regularly update clinical trial tracking tools and systems that provide metrics and tracking of a clinical trial’s progress, including patient recruitment, trial supplies and trial documentation.

• Support the study specific trial master file by filing and maintaining electronic trial master file (eTMF) for sponsor documents, review of eTMF plans and perform quality oversight of CRO eTMF throughout trial.

• Collaborate with CROs, vendors and clinical sites in performing the day-to-day activities of a clinical trial, including generating management status reports, tracking the collection, shipment, and analysis of all study samples and coordination of the distribution of clinical trial supplies, equipment, and laboratory kits.

• Track and process approved invoices and authorized clinical trial payments to selected vendors and study sites.

• Attend study team and department meetings while assisting with meeting logistics (scheduling, room and equipment set up, attendance tracking), agenda preparation, meeting minutes, and collating materials for meetings.

• Compile shipment request to 3rd party laboratory vendors, track and ensure samples received at vendors, follow up with sites/CRO for missing samples, and prepare/provide summary reports to clinical trial manager as requested.

• Assist in monitoring timelines, budgets, and clinical trial materials and supplies.

• Assist in the planning and preparation for Investigator meetings.

• Assist with document preparation for due diligence, audits and/or regulatory inspections.

• Complete quality control (QC) review of SOPs, protocols, informed consent, and other relevant study documents.

• Participate in special projects to continuously improve processes, tools and systems.

• Develop an understanding of clinical trial research through exposure to research protocols, the drug development process, clinical meetings, Company Standard Operating Procedures (SOPs), and Food and Drug Administration (FDA) guidelines as related to Good Clinical Practices (GCP).

• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.

• Other duties as assigned.

QUALIFICATIONS:

• Bachelor’s degree in health sciences or related field
• Clinical Trial Associate 1 requires 2+ years of relevant experience in pharma/biotech or CRO, or equivalent education and experience
• Clinical Trial Associate 2 requires 4+ years of relevant experience in pharma/biotech or CRO, or equivalent education and experience
• Ability to work on multiple clinical projects and manage priorities effectively
• Knowledge of clinical trial processes and ICH-GCP guidelines
• Ability to work both independently and as part of a multidisciplinary team
• Excellent written communication, oral communication, and organizational skills are required
• Proficient computer skills using Microsoft Word, Excel, PowerPoint, etc.
• Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility
• This position is intended for candidates with existing clinical trial experience in a pharmaceutical, biotechnology, or CRO setting. Due to the specialized nature of the role, only applicants who meet the stated experience requirements will be considered.

Benefits and Perks:

• base salary
• target bonus
• stock options
• medical
• dental
• vision
• short- & long-term disability
• accidental death & dismemberment
• life insurance programs
• Employee Assistance Program
• travel insurance
• retirement savings programs with company matching contributions
• vacation
• personal days
• sick days
• end-of-year company shutdown
• Training, Learning & Development program, including a Tuition Assistance program for advanced degrees

Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.