Position
Trial Start up Manager
Job description
Are you passionate about clinical research and ensuring trials are conducted to the highest standards? Do you thrive in a collaborative environment where your work directly impacts patients’ lives? If so, we invite you to join our team as a Trial Start-Up Manager. Read on and apply today for a life-changing career!
The position
As a Trial Start-Up Manager, you will play a critical role in preparing and coordinating all activities required to initiate clinical trials in Canada. Your responsibilities will include:
Preparing and submitting required documentation to health authorities and ethics committees.
Ensuring compliance with local regulations, Good Clinical Practice (GCP), and internal procedures.
Following up on regulatory processes until all necessary approvals are obtained.
Collaborating with internal teams (e.g., Clinical Operations, Regulatory Affairs) and healthcare professionals at study sites.
Overseeing trial progress to ensure adherence to protocols, SOPs, and regulatory requirements.
Developing and maintaining relationships with clinical investigators, medical educators, CROs, and research institutions.
Qualifications
We are looking for a candidate with the following qualifications:
University degree in Life Sciences or equivalent.
Minimum of 2 years of experience in a role related to clinical start-up.
Good knowledge of GCP (Good Clinical Practice) and local regulatory requirements.
Strong understanding of Standard Operating Procedures (SOPs) in clinical research.
Experience in preparing and submitting Clinical Trial Applications (CTAs) to regulatory authorities and ethics committees.
Ability to follow up on regulatory processes until study approval.
Capability to collaborate with multiple internal departments (Regulatory Affairs, Clinical Operations, etc.).
Willingness to travel up to 20%, both nationally and internationally.
Nice-to-Have
Previous experience with electronic regulatory systems (such as Vault RIM).
Knowledge in managing national content for regulatory documentation.
Experience working in multicultural or global environments.
Familiarity with regulatory processes in different countries (if applicable to an international setting).
Advanced skills in project management or digital tracking tools.
About the department
Our department in Canada is dedicated to running all clinical development activities, from initial planning of clinical trials to authority submission. We provide resources, processes, and competences in Biostatistics and Programming, Clinical Reporting, Data Management, Epidemiology/Real World Evidence, and Clinical Pharmacology to all development projects. 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
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.
Contact and Deadline
To complete your application, please click "Apply now" attach your CV and follow the instructions. For more information, please follow us on LinkedIn: Novo Nordisk: About | LinkedIn
Deadline
Apply before June 4th, 2025.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
