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Start Up Specialist - French Speaker - Sponsor dedicated - Home Based Canada

Updated: Yesterday

Location: Toronto, ON, Canada

Job ID:

Senior Start Up & Regulatory Specialist (French speaking) – sponsor dedicated. This role is based at home in Canada and involves managing study start‑up activities, document management, and regulatory submissions as the key point of contact for local study teams and external stakeholders.

Job Responsibilities

- Independently manage multiple country, study and site level deliverables during start‑up and maintenance both within the laboratory and external business partners and vendors, when required.
- Plan and develop strategy for start‑up activities to ensure successful recruitment and delivery to trial milestones.
- Prepare investigator sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
- Support local regulatory in preparing and performing submissions to Health Authorities, including follow‑up until approval; this includes substantial amendments and any other documentation requiring HA submission.
- Prepare and perform submissions for Ethics Committees, including follow‑up until approval (protocol, amendments/IB and any other documents requiring EC submission).
- Collaborate with internal roles in country feasibility and site selection.
- Collaborate directly with internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines.
- Prepare country Informed Consent Form (ICF) and manage country ICF template.
- Review and approve Site ICFs.
- Review and approve Clinical Trial Package (CTP) documentation.
- Update national registries as applicable.
- Ensure that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management.
- When applicable, conduct drug/IMP label review & translation.




- Serve as expert on country regulatory requirements and keep up to date with evolving regulation in collaboration with Regulatory and legal.
- May support collection and distribution of documents from/to sites including obtaining insurance certificates.
- May support Health Authority inspection and pre‑inspection activities.
- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.

Qualifications

- Fluent in French and English; Bachelor’s or Master’s degree in Life Sciences or equivalent.
- Minimum 3 years experience as a SSU Specialist, including coordination of trial start‑up activities and Health Authority/Ethic Committee submissions.
- Thorough understanding of GCP, ICH Guidelines and country regulatory environment.
- In‑depth knowledge and understanding of clinical research processes, regulations and methodology.
- Demonstrated organizational and planning skills and independent decision‑making ability.
- Experience leading or participating as an active member of cross‑functional teams, task forces or local and global initiatives.
- Strong organization and time‑management skills and ability to effectively manage multiple competing priorities.
- Strong critical thinking and risk‑analysis skills.

Advantages

- Competitive remuneration package with excellent benefits.
- Commitment to development and training, with opportunities to progress within a market‑leading and innovative organization.
- Opportunity to work in a successful and rewarding environment.

EEO Statement

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. All employment decisions will be made on the basis of merit, qualifications, experience and performance, and are not based on race, color, religion, national origin, sex, gender identity, sexual orientation, age or any other characteristic protected by law.

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📌 Start Up Specialist - French Speaker - Sponsor dedicated - Home Based Canada (Toronto)
🏢 Syneos Health
📍 Toronto