Senior Project Specialist (Clinical Trial Assistant) – Bilingual English/French Preferred

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Project Specialist (Clinical Trial Assistant) – Bilingual English/French Preferred based in Canada.

This role offers the opportunity to support global clinical trials within a sponsor-dedicated environment, contributing to the successful delivery of innovative healthcare research. As a Senior Project Specialist, you will play a key role in clinical trial operations, ensuring accurate documentation, regulatory compliance, and efficient study coordination. The position focuses on Trial Master File management, study startup activities, clinical document oversight, and cross-functional collaboration. You will work closely with clinical teams, project leads, sponsors, and investigative sites to support milestones and maintain inspection readiness. This fully remote opportunity is designed for professionals who value organization, autonomy, and meaningful contributions to advancing patient-focused therapies. The role provides exposure to global clinical research programs while supporting continuous improvement and operational excellence.

Accountabilities:: The Senior Project Specialist provides essential clinical trial administration and project coordination support across multiple studies. This role ensures study documentation, timelines, compliance requirements, and operational activities are managed effectively while collaborating with internal and external stakeholders.

Manage, organize, reconcile, and maintain Trial Master Files (TMF) within Veeva Vault, ensuring completeness, accuracy, and inspection readiness.

Collect, review, track, and archive essential regulatory and clinical study documentation according to established requirements.

Support study startup activities, including document collection, tracking, site activation coordination, and regulatory submission support.

Monitor study timelines, milestones, enrollment activities, deliverables, and operational metrics.

Coordinate project meetings by preparing agendas, recording minutes, tracking action items, and supporting follow-up activities.

Maintain project trackers, status reports, KPIs, study metrics, and operational reporting documentation.

Ensure clinical trial documentation follows SOPs, Good Clinical Practice (GCP), regulatory standards, and quality requirements.

Support audit and inspection readiness activities, including quality reviews, corrective action follow-up, and document archiving.

Operate independently in a remote environment while acting as a key resource for assigned project responsibilities.

Provide guidance and mentorship to junior project support team members when appropriate.

Requirements:

The ideal candidate has hands-on clinical trial administration experience, strong document management capabilities, and the ability to coordinate complex research activities in a highly regulated environment. Strong organizational skills, attention to detail, and bilingual capabilities are important for success in this role.

2–3+ years of experience working as a Clinical Trial Assistant (CTA) within a clinical research environment.

Demonstrated direct experience supporting clinical trials and managing clinical documentation.

Hands-on experience with Veeva Vault Trial Master File (TMF) management is required.

Strong knowledge of clinical trial documentation processes, study startup activities, and regulatory requirements.

Experience tracking study milestones, operational metrics, enrollment activities, and project deliverables.

Excellent organizational skills with the ability to manage large volumes of information accurately.

Strong written and verbal communication skills with the ability to collaborate across multiple stakeholder groups.

Ability to work independently, prioritize tasks, and manage deadlines in a remote setting.

English proficiency required; French proficiency preferred, with the ability to review French-language documents. Strong reading and written comprehension in French is highly valued.

Experience working in a sponsor-dedicated model, supporting regulatory submissions, or mentoring junior team members is considered an asset.

Benefits:

Competitive compensation package aligned with experience and qualifications.

Fully remote work opportunity available across Canada.

Opportunity to support impactful global clinical research programs advancing healthcare innovation.

Collaboration with experienced professionals across clinical operations and life sciences.

Career development opportunities through training, knowledge sharing, and professional growth programs.

Exposure to innovative clinical trial processes, technologies, and global healthcare initiatives.

Inclusive and collaborative work environment focused on employee development and meaningful contributions.

Opportunities to contribute to projects that help improve patient outcomes worldwide.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1