Study Start-up Lead

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases? Then this is your moment. Apply now and join the Novo Nordisk's Study Start-Up Lead (SSUL). Together we can create life-changing innovation. Together we can make it happen. Join us and apply today!
About the department
The Clinical, Medical, Regulatory (CMR) department is one of the key functions that enable the business strategy through effective execution of functional goals, in the areas of Clinical Research, Medical Affairs, and Regulatory.
Our organization has been globally recognized as the Best Place to Work, topping the ranks for two consecutive years in 2022 and 2023. It is an exciting time to join Novo Nordisk and be part of a dynamic company in an even more dynamic industry, helping us achieve our aspirations to establish a global presence.
The position
As a Study Start-Up Lead (SSUL), you will be in-charge of leading and managing start-up activities for Clinical Trials in CDC Korea, overseeing amendments, and ensuring compliance with trial timelines from country allocation to Site Initiation Visits. You will collaborate with internal and external stakeholders to ensure all necessary activities leading up to site initiation are conducted in accordance with regulatory requirements, NN SOPs, and Protocol timelines and participate in regional and global communications regarding start-up activities and teams to accelerate start-up. You will ensure all relevant activities are carried out in compliance with applicable regulatory requirements, Novo Nordisk Standard Operating Procedure (SOP)s, and Protocols.
The role tasks are as follows but are not limited to:

• Prepare and manage clinical trial documents for start-up and IRB/HA submissions by adapting them to country/site requirements, overseeing translations, and ensuring compliance with local regulations while collaborating with CRS on common documents.
• Obtain IRB/HA's approval in a timely manner and oversee start-up timeline: Address queries from IRB and HA and prepare responses in consultation with the trial team with proactively informing the start-up plan and status.
• Prepare and negotiate site-level budgets and investigator agreements, manage contract templates in coordination with legal departments, modify agreements with CDC-TM, ensure timely execution before site activation, and oversee contract amendments for ongoing trials while ensuring executed contracts are uploaded in COUPA.
• Maintain and update systems and filing related to clinical trial activities and handle protocol and ICF amendment for ongoing trials with managing the timeline and resource assignment for amendment-related tasks.
• Facilitate onboarding and training for Study Start-Up Associates and Clinical Regulatory Specialists, provide daily support and communication, ensure quality oversight of SSU procedures, coach staff, and develop strategies to enhance trial timelines, risk management, country allocation, and recruitment processes.

Qualifications

• Bachelor's degree or higher is essential, preferably in the discipline of Life Sciences, Medicine or Pharmacy.
• At least 5 years of experience in multinational clinical trials phases 2-3, including extensive involvement in start-up related tasks.
• Proficiency in IRB/EC requirements and regulations associated with IND is essential.

Working at Novo Nordisk
At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales - we're all working to move the needle on patient care.
Contact
Kindly upload your CV to our online career page (click on Apply and follow the instructions).
Deadline
Until the completion of recruitment
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
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.
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