Site Activation Specialist, French Speaker

Syneos Health

. Responsible for country-level quality deliverables and compliance with project requirements and applicable country rules .

Posted 9/24/2026full-timeMontreal • CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing country-level quality deliverables and compliance within clinical trial processes, including regulatory submissions and site activation. Proficient in project management, vendor negotiation, and maintaining adherence to SOPs and GCP standards.

Highest-signal resume keywords

Clinical Trial Process UnderstandingRegulatory Submissions ManagementProject Budget ManagementStrong Communication SkillsFrench Language Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Start-Up ProcessesICH GCP ComplianceRegulatory Authority ApplicationsEthics Committee ApplicationsProject Financial MonitoringSOPs and Work Instructions ComplianceData Protection GuidanceVendor ManagementQuality ControlProblem-Solving

Soft Skills

Organizational SkillsInterpersonal SkillsNegotiation SkillsTeam CollaborationIndependent Work

Tools & Technologies

SSU Tracking SystemTrial Master File

Certifications & Qualifications

Bachelor’s Degree

Industry Keywords

Site Start-UpCompetent AuthoritiesEthics CommitteesClinical ProtocolsStudy Specifications

About the role

Key responsibilities & impact

Responsible for country-level quality deliverables and compliance with project requirements and applicable country rules
Track submission and approval milestones in the SSU tracking system and investigate or escalate timeline delays
Monitor basic project financial aspects and contracted hours/tasks
Review and comply with SOPs and Work Instructions and maintain training records and timesheet compliance
Support quality improvement across Site Start-Up components, including submissions, essential document collection, and communication with Competent Authorities and Ethics Committees
Ensure relevant documents are submitted to the Trial Master File
Prepare and submit Central and Local Ethics Committee applications, Regulatory Authority applications, and other local regulatory or hospital approval submissions
Prepare ongoing submissions, amendments, periodic notifications, and safety notifications as required
Liaise between investigational sites and functional leads and oversee the end-to-end site activation process
Provide country-level regulatory intelligence and support data protection guidance
Provide input to local SOPs, Work Instructions, and internal training materials
Support Ethics Committee or Competent Authority issue resolution
Support site selection and feasibility activities
May support investigator contract and budget negotiation, contract preparation, quality control, execution, archival, and metadata capture

Requirements

What you’ll need

Bachelor’s Degree
Detailed understanding of clinical trial process across Phases II-IV and ICH GCP
Ability to understand clinical protocols and associated study specifications
Detailed understanding of clinical trial start-up processes
Ability to manage external vendors to contract effectively
Strong organizational skills with ability to handle multiple tasks effectively
Strong written and verbal communication and interpersonal skills
Ability to manage multiple project budgets with increased complexity and value
Quality-driven in all managed activities
Good negotiating skills
Good problem-solving skills
Demonstrated ability to work independently as well as part of a team
French speaker

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations when appropriate