Job Description

Study Start‑ Up Manager (Bilingual English / French Mandatory)

Location: Canada, Home based

About the role

We are expanding our Clinical Research team and are looking for a Study Start‑ Up Manager to support clinical trials across Canada.
This is an individual contributor role with end‑ to‑ end responsibility for study start‑ up and regulatory submission activities at country and site level, ensuring timely activation and full regulatory compliance.

The role will act as a key point of contact with Ethics Committees across Canada, requiring strong knowledge of federal and provincial regulations, including Quebec.

Key responsibilities

• Lead and manage study start‑ up activities and regulatory submissions for assigned clinical trials at country and site level.

• Prepare, review and submit dossiers to Health Authorities, IRBs and Ethics Committees across different Canadian provinces.

• Manage Informed Consent Forms (ICFs), including French versions, and coordinate updates requested by ECs or HAs.

• Coordinate site activation activities, including green‑ light readiness and regulatory milestones.

• Maintain accurate documentation and tracking in CTMS and eTMF systems.

• Collaborate closely with internal cross‑ functional teams, vendors and external stakeholders.

• Proactively identify and mitigate regulatory or start‑ up risks.

• Ensure compliance with ICH‑ GCP, local regulations and internal SOPs

Must‑ have requirements

To be successful in this role, candidates must meet the following criteria:

• Strong hands‑ on experience with Canadian regulations, including federal and provincial requirements

• Direct experience managing clinical trials at country level in Canada (not global‑ only exposure).

• Solid experience with IRB submissions and Ethics Committee interactions across multiple provinces.

• Bilingual English and French (mandatory), including ability to:

• Proven clinical trials background with experience in:

• Experience working within a Sponsor or CRO environment, with ability to manage complex workloads.

• Bachelor’s degree in Life Sciences, Pharmacy or a related field.

Nice to have

• Flexibility in years of experience, as long as strong hands‑ on clinical and regulatory expertise is demonstrated.

• Experience across different areas of clinical operations, regulatory or study start‑ up, with transferable skills.

• Advanced degree in a life sciences‑ related field.

• Experience supporting multiple trials simultaneously in a fast‑ paced environment.

About the department 

Our department in Canada is dedicated to running all clinical development activities, from initial planning of clinical trials to authority submission. Our team supports trial execution by aligning processes, developing competencies, sharing knowledge, and providing training across trial management and medical staff. Join us in a fast-paced and dynamic environment where your contributions will make a significant impact. 

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.

What we offer

At Novo Nordisk, you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary:For this role, the annual base salary ranges from $116,680.00 - $ 166,680.00. The placement in the salary range will be assessed during the recruitment process based on your skills, competencies, and knowledge, and how your relevant experience matches the position requirements.

Benefits: The eligibility for specific benefits may vary based on the job and location.

Learn more about our Reward Philosophy here.

More information

This job posting is for a new full time employee.

For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn, and YouTube.

To complete your application, click “Apply now,” attach your CV, and follow the instructions.

Application Deadline: May 6th, 2026

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.