Study Start Up Lead

F. Hoffmann-La Roche AG; Mississauga; On-site; CAD 89,000 - 117,000; Full time

Job summary

Roche is seeking a Country Study Start-Up professional within Pharma Product Development Global Clinical Operations (PDG) to drive efficient initiation of clinical trials. You will lead the country strategy for a disease area, oversee start-up operations to ensure timely site activation and regulatory compliance, and collaborate with external partners to improve timelines.

The role requires a life sciences degree with 1–3 years of submissions experience, knowledge of ICH-GCP and EU CTR, and

Qualifications

• Degree in life sciences with 1–3 years of submissions experience.
• Proven track record in managing site relationships and complex trial start-up.
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
• Fluency in English is mandatory.

Responsibilities

• Lead country strategy in a disease area for study start-up.
• Oversee start-up operations for site activation and regulatory compliance.
• Identify opportunities for process automation, standardization, and innovation at country and site levels.
• Collaborate with regional and global counterparts to harmonize systems and improve timelines.
• Oversee development and management of clinical trial submissions and amendments, ensuring regulatory coordination.
• Provide budgeting and contract management oversight, including budget strategies and negotiations.
• Participate in external industry collaborations to influence the country’s start-up environment.

Skills

Clinical trial start-up

Education

Life sciences degree

Postgraduate in clinical trials

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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.

The Opportunity

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

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.

Relocation Benefits

• Relocation Benefits are not available for this job posting.

The expected salary range for this position based on the primary location of Mississauga is 89,256.00 and 117,148.50 of hiring range.

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Acreditamos ser necessário oferecer soluções médicas agora – mesmo quando desenvolvemos inovações para o futuro. Nosso compromisso é transformar a vida dos pacientes. Temos coragem para decidir e agir. Acreditamos também que bons negócios significam um mundo melhor. É para isso que trabalhamos diariamente. Temos compromissos com o rigor científico, com a ética e com o acesso a inovações médicas para todos. Fazemos isso hoje para construir um amanhã melhor. Temos orgulho de quem somos, do que fazemos e de como fazemos. Somos muitos, trabalhando como um em todo o mundo. Somos Roche.