[Hiring] Senior Project Specialist (Clinical Trial Assistant) @Syneos Health

Role Description

As a Senior Project Specialist, you will provide essential operational and project support across multiple clinical studies. This position is heavily focused on Trial Master File (TMF) management within Veeva Vault, clinical document coordination, study startup support, and ongoing project administration.

You will partner closely with Project Leads, study teams, investigative sites, and sponsors to ensure study documentation, compliance requirements, and project milestones are managed accurately and efficiently.

Job Responsibilities

• Trial Master File & Document Management
  • Maintain, organize, and reconcile Trial Master Files (TMF) within Veeva Vault.
  • Collect, review, track, and file essential and regulatory study documents.
  • Ensure TMF completeness, inspection readiness, and compliance with study requirements.
  • Support study startup document collection and tracking activities.
• Clinical Trial Support
  • Track study timelines, milestones, enrollment activities, and protocol-related deliverables.
  • Support site activation and study startup processes.
  • Assist with regulatory submissions and related documentation activities.
  • Help coordinate study supplies and operational logistics as needed.
• Project Coordination
  • Schedule meetings, prepare agendas, capture meeting minutes, and track action items to completion.
  • Support internal and external project meetings with study teams, sponsors, and investigative sites.
  • Maintain project trackers, status reports, KPIs, and study metrics.
  • Prepare and distribute study-specific operational and financial reports.
• Compliance & Quality Support
  • Ensure study documentation is maintained according to company SOPs, GCP, and regulatory requirements.
  • Support inspection and audit readiness activities.
  • Assist with quality review processes and follow-up of corrective actions.
  • Archive study documentation according to established policies and guidelines.
• Leadership & Collaboration
  • Operate independently with minimal day-to-day supervision.
  • Act as a key project resource and escalation point for assigned responsibilities.
  • Mentor and support junior Project Specialists when appropriate.
  • Serve as a project representative during internal and external audits.

Qualifications

• 2–3+ years of Clinical Trial Assistant (CTA) experience in a clinical research setting.
• Direct CTA experience must be clearly demonstrated on your resume.
• Strong experience managing large volumes of clinical trial documentation.
• Hands-on experience with Veeva Vault TMF required.
• Excellent organizational skills and exceptional attention to detail.
• Experience supporting study startup activities and document collection processes.
• Strong communication and stakeholder management skills.
• Ability to work independently in a remote environment.
• English proficiency required.
• French proficiency preferred; candidates should be comfortable reviewing French-language documents.

Preferred Qualifications

• Experience working in a sponsor-dedicated model.
• Experience supporting regulatory submissions.
• Familiarity with clinical trial systems, KPIs, enrollment tracking, and study reporting.
• Experience mentoring junior team members.

Location

• Remote – Canada
• Candidates located in Eastern Canada are preferred due to collaboration with teams in the Montreal/Quebec region.
• Exceptional candidates located elsewhere in Canada will also be considered.

Why Join Us?

• Work in a dedicated sponsor environment on impactful clinical research programs.
• Fully remote flexibility within Canada.
• Opportunity to partner with experienced clinical operations professionals.
• Contribute to studies that help advance innovative therapies and improve patient outcomes.