Start-Up Team Manager

Category:  Clinical Development
Location: 

Kfar Saba, Israel, IL

   

Are you ready to lead and manage a Start-Up team? Do you have experience in executing clinical trials and ensuring compliance with regulations? If so, we have an exciting opportunity for you to join our team as a Start-Up Team Manager at Novo Nordisk Israel. Read on to learn more and apply today for a life-changing career.

 

The Position

As a Start-Up Team Manager, you will be responsible for executing the Start-Up team activities in clinical trials performed in Israel, ensuring compliance with local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements.

In addition, you will have the following responsibilities:

  • Manage and lead the Start-Up team, set and monitor performance targets and KPIs for the team and functional area in close cooperation with Israel’s Clinical Development Center (CDC) Director and with the Therapeutic Area (TA) Heads.
  • Ensure preparation and submission of local Clinical Trial Application to Health Authorities and Ethics Committees (ECs) to obtain all necessary regulatory approvals within defined timelines.
  • Deliver reliable, high-quality data and ensure study participants’ protection to activate sites prior to FPFV (First Patient First Visit) in the country.
  • Manage the lifecycle of clinical trial agreements/contracts, including sub-contractors, across trials.
  • Execute regulatory submissions of Clinical Trial Applications (CTA) and ongoing submissions and obtaining approvals.

 

Qualifications

  • B.Sc. in Life Science, Pharmacy/nursing qualification or equivalent, M.Sc. in Life Science would be an advantage.
  • Basic GCP qualification.
  • At least 3 years of experience as a Start-Up Team member.
  • At least 2 years of direct people management-Preferred.  
  • Conceptual and strategic approach to the clinical organization development with strategic insight to trial Start-Up and supporting processes in the clinical trial conduct.
  • Strong track record in clinical trial execution in multifunctional team at country level, including clinical quality (audits and inspections) and training.
  • Strong leadership and management skills to build and manage the start-up team.
  • Excellent communication and collaboration skills to work closely with the CDC Director and with the TA Heads and CQTM.
  • Experience in executing regulatory submissions of Clinical Trial Applications (CTA) and obtaining approvals.
  • Fluency in Hebrew and English.

 

About the Department

Our team is focused on executing clinical trials and ensuring compliance with regulations to deliver reliable, high-quality data and protect study participants. We work closely with the CDC Director and other TA Heads to set and monitor performance targets and KPIs.

 

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. 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

For further information please apply your CV via the online recruitment system.

 

Deadline

Apply before 07/03/2024

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.