Clinical Trial Specialist - French Speaking Clinical Operations · ·

Emerald Clinical Trials Inc.; Canada; Hybrid; CAD 83,000 - 124,000; Full time

Benefits offered by this job

Competitive compensation

Hybrid/Remote options

Career growth

Wellbeing programs

Global opportunities

Job summary

Emerald Clinical Trials Inc. in Canada seeks a Clinical Trial Specialist (CTS) to support site start-up and TMF management, ensuring trials comply with ICH/GCP and regulatory requirements. You will coordinate TMF filing, QC, audits, feasibility work, and liaise with CRA/CTM/PM.

Fluency in French and English is required; hybrid or remote work is available depending on location and role. This role offers a path to global projects with diverse teams and exposure to regulatory submissions, data

Qualifications

• Degree or 2 years related experience or training
• Ability to perform general administrative duties
• Exposure to medical terminology preferred
• Knowledge of ICH/GCP, ethical and regulatory requirements preferred
• Must be fluent in French & English

Responsibilities

• Increase proficiency in Trial Master File (TMF) set-up and maintenance
• Upload and maintain TMF files in file-sharing system
• Serve as second reviewer for TMF QC
• May function in TMF Lead Role for TMF setup and oversight
• Assist with end of study TMF filing, QC and archival
• Develop skills in audit responses
• Perform QC of documents and emails for quality
• Maintain data entry for Clinical Trial Management System
• Assist with data entry support and investigator payments
• Work with CRA/CTM/PM during site start-up for feasibility
• Present feasibility results to PM team or Sponsor
• Assist with preparing essential document packets (EDPs)
• Submit final EDPs to sponsor or CTM/PM

Skills

Administrative skills

Bilingual French/English

Medical terminology exposure

Education

College/University diploma or degree

Tools

TMF filing system

Job description

At Emerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing.

Our therapeutic expertise spans renal, cardiometabolic, and oncology - areas where we make a significant impact on improving global health.

At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results- bringing therapies to patients in need.

Why Join Us?

At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first - both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here’s what makes us stand out:

• Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.
• Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.
• Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

About the Role

The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Federal Regulations, ICH guidelines, appropriate project plans, IRB/Ethic Committee requirements, and applicable SOPs and guidelines. The CTS works closely with project team to help manage clinical trial feasibility processes, coordinate clinical trial start‑up activities including collection of essential documents for site initiation/startup, submissions to central IRBs/Ethic Committees, supporting site staff in the submission to local IRBs/Ethic Committees and changes to Informed Consent Forms (ICFs).

Your Responsibilities

• Increase proficiency in Trial Master File (TMF) set-up and maintenance (filing), both hard copy and electronic as assigned by project .

• Increase proficiency in uploading and maintaining TMF files and folders in George Clinical’s file-sharing system by project as assigned

• Serve as second reviewer for TMF QC .

• May function in the TMF Lead Role and assume responsibility for TMF setup, maintenance and oversight.

• Assist with/complete end of study TMF filing (including site close out documents), QC and archival.

• Further develop skills in preparing and participating in audit responses.

• Perform QC of work (documents, emails etc.) prior to sending out to ensure quality product deliverables .

• Further develop skills and knowledge of data entry and maintaining files/folders for Clinical Trial Management System by project as assigned.

• Further develop skills and knowledge of assisting with data entry support, tracking and submission for investigator payments by project as assigned.

• Works with CRA/CTM/PM during site start-up for feasibility, serving as point of contact for sites where applicable .

• Assist with presenting final feasibility results to PM team and/or Sponsor.

• Assists the sites in preparation, planning, organizing and collecting essential document packets (EDPs).

• Submit final EDPs to sponsor or CTM/PM as required

About You

• College / University diploma / degree; OR at least 2 years related experiences and / or training; OR equivalent combination of education and experience .

• Ability to perform general administrative duties as needed or required .

• Exposure to medical terminology preferred.

• Knowledge of ICH/GCP, ethical and regulatory requirements preferred

• Must be fluent in French & English

What We Offer

• Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
• Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
• Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
• Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
• Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

We are an equal-opportunity employer and encourage applications from all qualified candidates.

The expected salary range for this position is $60,000 - $90,000 per year, depending on experience and qualifications. This range is in USD and there may be an adjustment for salaries in Canada.