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

.

- Robust 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.

- Strong 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 (Mississauga)
🏢 Integrated Resources, Inc ( IRI )
📍 Mississauga