Site Activation Partner I

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee and facilitate operational activities from commencement to completion for designated studies and investigational sites.

• Ensure compliance with deliverables, deadlines, and quality benchmarks.

• Manage regulatory, ethical, and essential study documentation throughout the entire study lifecycle.

• Initiate and coordinate the preparation of investigator site initiation kits.

• Prepare and submit requests for regulatory approvals while collaborating with both global and local Regulatory Affairs teams.

• Maintain continuous communication with study teams and investigational sites.

• Oversee document updates, including protocol amendments and approvals from ethics committees.

⛳️ Requirements

• Degree/certificate or an equivalent combination of education, training, and experience; a bachelor's degree in science/arts or life sciences is preferred.

• At least 4 years of relevant experience in a clinical trials and site activation setting.

• Experience in the pharmaceutical sector or with a clinical research organization is advantageous.

• Proven strong understanding of clinical trial methodologies, ICH-GCP, FDA regulations, and local laws.

• Proficient in the local language and English.

• Proficiency in additional languages is a plus.

• Bilingualism (French and English) – the candidate must communicate effectively in English due to interactions with stakeholders and colleagues outside of Quebec or Canada.

• Excellent oral and written communication skills both internally and externally.

• Strong technical abilities and the capacity to learn and utilize multiple systems.

• Experience in a global work environment.

• Experience working in multiple countries is a benefit.

• Experience leading or actively participating as a member of cross-functional teams and working groups.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off