Biostatistician designing real - world evidence studies from EMR and claims data for Syneos Health. Applying causal inference, trial emulation, and statistical programming across healthcare projects.
About the role
- Clinical Trial Specialist supporting French-speaking site start-up, TMF management, and regulatory submissions for Emerald Clinical Trials, a global clinical research CRO.
Responsibilities
- Support clinical trial activities as the in-house site start-up and maintenance specialist
- Help ensure clinical trials comply with Federal Regulations, ICH guidelines, project plans, IRB/Ethics Committee requirements, and applicable SOPs and guidelines
- Manage clinical trial feasibility processes with the project team
- Coordinate trial start-up activities, including collection of essential site documents
- Submit materials to central IRBs/Ethics Committees
- Support site staff with local IRB/Ethics Committee submissions and informed consent form changes
- Set up, maintain, review, quality-check, and archive Trial Master Files
- Upload and maintain TMF files and folders in the file-sharing system
- Serve as second reviewer for TMF quality control and potentially lead TMF setup, maintenance, and oversight
- Prepare and participate in audit responses
- Quality-check documents and emails before distribution
- Maintain Clinical Trial Management System data and files/folders
- Support investigator payment data entry, tracking, and submissions
- Work with CRA/CTM/PM during site start-up and serve as a site point of contact where applicable
- Assist with presenting final feasibility results to the project management team and/or sponsor
- Assist sites with preparing, planning, organizing, and collecting essential document packets
- Submit final essential document packets to the sponsor or CTM/PM
Requirements
- College / University diploma / degree; OR at least 2 years related experience 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 and English
- Knowledge of Federal Regulations, ICH guidelines, IRB/Ethics Committee requirements, and applicable SOPs and guidelines
- Ability to support clinical trial feasibility, site start-up, essential document collection, IRB/Ethics Committee submissions, and informed consent form changes
Benefits
- Purpose-driven work contributing to clinical trials improving lives
- Hybrid or remote working arrangements, depending on location and role
- Learning opportunities and access to a global network of scientific leaders
- Employee wellbeing programs promoting work-life balance, health, and team connection
- Global engagement surveys
- Recognition programs
- Team-building events
- Exposure to diverse international projects and clients
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Senior Clinical Scientist leading infectious - disease and HIV clinical trial science at ICON, a global healthcare intelligence and clinical research organisation. Driving protocols, medical monitoring, data review, and regulatory deliverables.
Principal Clinical Data Manager leading clinical research data management, quality, and database lock activities at Veristat. Managing complex studies and mentoring clinical data management teams.
Biostatistician II leading statistical analyses and clinical - trial documentation for Altasciences’ drug - development programs. Using SAS to support sponsors, regulatory submissions, and preclinical projects.
Clinical Research Associate II monitoring oncology clinical trials for IQVIA Biotech, a global clinical research services CRO. Managing sites from start - up through close - out.
Senior Clinical Research Associate monitoring Pfizer clinical trials across remote Canadian investigator sites. Ensuring patient safety, regulatory compliance, recruitment and study closeout.
Senior Clinical Research Associate managing oncology trial sites for Worldwide Clinical Trials, a global contract research organization. Overseeing study start - up, site maintenance, safety reporting, and closeout across Canada.
Senior Clinical Research Associate conducting onsite monitoring and regulatory support for a global medical research company in Canada. Managing clinical - trial sites, CRFs, queries, audits, and study submissions.
Clinical Research Associate II monitoring Phase I - III clinical trials for AbbVie, an innovative medicines company. Managing site compliance, data quality, safety reporting, and investigator relationships with at least 50% travel.
Clinical Trial Manager overseeing site, clinical and central monitoring for Syneos Health’s integrated life - sciences services. Managing risks, compliance, study systems and delivery milestones across clinical trials.