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

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

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Senior Project Specialist (Clinical Trial Assistant)

**Bilingual English/French Preferred**

Sponsor-Dedicated | Remote | Canada

Are you an experienced Clinical Trial Assistant (CTA) looking to take the next step in your clinical research career? We are seeking a highly organized, detail-oriented Senior Project Specialist to support global clinical trials within a sponsor-dedicated environment. This fully remote opportunity offers the chance to play a critical role in study execution, Trial Master File management, and cross-functional project coordination while working with a high-performing clinical team.

About the Role

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.

What You'll Do

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.

What We're Looking For

Required 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.

Language Requirements

• English proficiency required.

• French proficiency preferred.

• Candidates should be comfortable reviewing French-language documents. Reading and written comprehension are highly valued, while fluent spoken French is not required but a huge plus !

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.

Ready to make an impact in clinical research? Apply today and help drive the success of innovative clinical trials from startup through completion.

Important Note

This role requires prior Clinical Trial Assistant (CTA) experience and the ability to read and write in both English and French . Candidates must clearly demonstrate direct CTA experience and bilingual language capabilities on their resume. Applicants who do not meet both requirements will not be considered for this position.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

The Senior Project Specialist is responsible for maintaining and coordinating the logistical aspects of clinical projects, and provides overall support to functional leads to ensure the successful completion of project deliverables The Senior Project Specialists supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers’ requirements. Operate independently, with minimal day to day oversight, and may co-ordinate the activities of Project Specialists