Senior Project Specialist (Clinical Trial Assistant) – Bilingual English/French Preferred (Sponsor Dedicated/Remote -Canada)

Syneos Health • Unorganized Thunder Bay District, ON

1d • Remote

About The Position

Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and shape solutions. This role is within a Functional Service Provider partnership or a Full-Service environment, collaborating with problem solvers to help customers achieve their goals. The company is agile and driven to deliver for colleagues, customers, and those in need. Syneos Health focuses on developing its people through career development, training, and recognition. They are committed to building an inclusive culture with a purpose of 'Driven to Deliver,' shaping solutions that can dramatically impact lives. They aim to build a company that employees want to work for and customers want to work with, believing that bringing together smart colleagues globally can shape the future of healthcare and define the pace of patient progress.

Requirements

• 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.
• Candidates should be comfortable reviewing French-language documents. Reading and written comprehension are highly valued.

Nice To Haves

• Bilingual English/French Preferred
• French proficiency preferred.
• Fluent spoken French is not required but a huge plus!
• 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.
• Candidates located in Eastern Canada are preferred due to collaboration with teams in the Montreal/Quebec region.

Responsibilities

• Provide essential operational and project support across multiple clinical studies.
• Focus on Trial Master File (TMF) management within Veeva Vault, clinical document coordination, study startup support, and ongoing project administration.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• career development and progression
• supportive and engaged line management
• technical and therapeutic area training
• peer recognition
• total rewards program
• inclusive culture
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed