Title : Study Start up Lead
Work Location: Mississauga ON -3 days onsite
Duration -12 months
This is an onsite role located within the Client Mississauga campus. Selected candidate is required to work at the client Mississauga Campus minimum of three (3) times every week.
Description:
This role focuses on the efficient and compliant initiation of Client -sponsored clinical trials by developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance.
Key responsibilities include:

• Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.
• Ensuring alignment with global strategies and timelines.
• Managing amendments throughout the study lifecycle.
• Identifying and driving opportunities for process automation, standardization, and innovation.
• Collaborating with regional and global counterparts to harmonize systems and improve timelines.
• Participating in external industry collaborations to influence country start-up environments.
• Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities).

Skills and Qualifications:

• Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable
• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments
• Experience managing vendor/CRO relationships

Who You Are:

• You have a degree (MD, PhD, MA/MS, BA/BS) in life sciences or a related field with 1-3 years of experience in submissions, and cross-functional collaboration
• You have demonstrated experience in clinical trial start-up
• Proven track record in managing site relationships with a customer centric mindset and managing complex clinical trials start-up
• You possess a strong understanding of ICH-GCP, EU CTR, and local regulatory environments
• You have excellent communication, interpersonal, and problem-solving skills, with a collaborative mindset
• Fluency in written and spoken English is mandatory
• Ability to manage multiple priorities and work in a fast-paced, dynamic environment
• Ability to travel if needed.

Preferred:

• A postgraduate degree in clinical trials or clinical research is highly desirable.

Mandatory Skills Required:

• Excellent communication and interpersonal skills
• Strong organizational, analytical, and problem-solving capabilities
• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.)
• Collaborative and adaptable mindset with attention to detail
• Ability to lead through complexity and ambiguity, especially in matrixed and global teams
• Fluency in written and spoken English is mandatory.
• Fluency in written and spoken language(s) of the host country is mandatory.