Study Start Up Lead

Roche • Mississauga, ON

5d • CA$89,256 - CA$117,149

About The Position

At Roche Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. Every role here connects to something real: the health and lives of patients. As a key member of our Country Study Start-Up team, you will drive and facilitate the efficient initiation of clinical trials, ultimately helping to deliver innovative treatments to patients.

Requirements

• Degree (MD, PhD, MA/MS, BA/BS) in life sciences or a related field.
• 1-3 years of experience in submissions and cross-functional collaboration.
• Demonstrated experience in clinical trial start-up.
• Proven track record in managing site relationships with a customer-centric mindset.
• Proven track record in managing complex clinical trials start-up.
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
• 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.

Nice To Haves

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

Responsibilities

• Lead the country strategy in a disease area for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
• Oversee start-up operations to ensure timely and efficient site activation and regulatory compliance.
• Identify and lead opportunities for process automation, standardization, and innovation at both the country and site levels.
• Collaborate with regional and global counterparts to harmonize systems and improve timelines.
• Oversee the development and management of clinical trial submissions and amendments, ensuring regulatory coordination.
• Provide strategic oversight for all aspects of budgeting and contract management, including developing budget strategies and negotiating with internal and external stakeholders.
• Participate in external industry collaborations to influence the country's start-up environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level