We are seeking an experienced Clinical Trial Start-Up skilled 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 settings.
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 Integrated Resources, Inc Iri Mississauga
🏢 Integrated Resources, Inc ( IRI )
📍 Mississauga