We are seeking an experienced Clinical Trial Start-Up professional to lead and optimize the initiation of Client-sponsored clinical trials. This role will develop and implement country-level start-up strategies, oversee site activation activities, ensure regulatory compliance, and drive process improvements across the study lifecycle.

Key Responsibilities

- Lead country-level study start-up strategy, driving efficiency, innovation, and collaboration with external stakeholders.
- Oversee start-up operations to ensure timely site activation and regulatory compliance.
- Ensure alignment with global study strategies, milestones, and timelines.
- Manage study amendments throughout the clinical trial lifecycle.
- Identify and implement opportunities for process automation, standardization, and innovation.
- Collaborate with regional and global teams to harmonize systems and improve start-up timelines.
- Participate in external industry collaborations to help influence and improve country start-up environments.
- Engage with government and institutional bodies, including Ethics Committees/Boards and Health Authorities,



regarding clinical trial policies and practices.

Qualifications & Skills

- Bachelor’s degree or higher (BA/BS, MA/MS, MD, or PhD) in Life Sciences or a related field.
- Master’s or postgraduate degree is highly desirable.
- Demonstrated experience in clinical trial start-up and regulatory submissions.
- Strong experience working cross-functionally within clinical research environments.
- Solid understanding of ICH-GCP, EU CTR, and local regulatory requirements.
- Experience managing CRO and vendor relationships.
- Proficiency with clinical systems such as Veeva Vault, CTIS, RIM, or similar platforms.
- Excellent communication, interpersonal, organizational, and analytical skills.
- Robust problem-solving abilities with exceptional attention to detail.
- Ability to work effectively in matrixed, global teams and lead through complexity and ambiguity.
- Fluency in written and spoken English is required.
- Fluency in the host country's local language(s) is required.

📌 Study Start-Up Clinical Lead (Toronto)
🏢 Integrated Resources, Inc ( IRI )
📍 Toronto