Study Start-Up Specialist

Are you experienced in clinical trial start-up activities? Do you have a strong understanding of local and global regulations? We are looking for a Study Startup Specialist to join our team in Türkiye. If you are detail-oriented, proactive, and passionate about ensuring the successful activation of clinical trial sites, then read on and apply today for a life-changing career.
 

The Position
As a Study Startup Specialist, you will be managing and executing start-up activities in allocated clinical trials. In addition, you will be ensuring compliance with local/global regulations, ICH-GCP, Novo Nordisk procedures, and protocol requirements. 
Your main responsibilities will be:

• You will own start-up activities, ensuring timely submission and First Patient First Visit (FPFV), and proactively flagging risks and issues
• You will review and customize trial-related documents as necessary
• You will prepare and submit local Clinical Trial Applications to Health Authorities and Ethics Committees for initial and ongoing to obtain necessary approvals within defined timelines
• You will establish and maintain relationships with internal and external stakeholders
• You will identify potential risks and take proactive action to prevent or mitigate
   

Qualifications
As a Study Startup Specialist, you need to have the ability to build and maintain strong working relationships with internal and external stakeholders. Moreover, you need to have a team-oriented personality with a high degree of flexibility and close collaboration with relevant roles to ensure successful start-up of trials. 
To be successful in this role: 

• A bachelor’s degree in Life Sciences such as Pharma, Chemistry, or Biology; Postgraduate study is a plus
• Minimum 2 years of start-up/regulatory submission experience in the pharmaceutical industry or Clinical Research Organization 
• Solid Knowledge of Global Content Plan (GCP) and regulation
• Proficiency in both written & Spoken English language 
• IT proficiency in Microsoft Office and applicable clinical trial systems

About the Department
Clinical Development Centre Turkey is responsible for all clinical operations activities within Türkiye and project management of clinical studies conducted in Ukraine, Lebanon, Saudi Arabia, Algeria, and Morocco. The team consists of more than 60 employees as TAs team members, Clinical Operations Excellence team members, and start-up team members.
 

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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact 
Please click on "apply now" to submit your resume in English. 

Deadline 
Apply before September 17th, 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.