CDC Trial Manager

Are you an expert in project management of clinical trials? Would you like to use your experience to continuously optimise the way trials are conducted? Do you want to be part of our Clinical Development Centre (CDC) which includes Türkiye, Ukraine, Lebanon, Saudi Arabia, Algeria, and Morocco? Join Novo Nordisk as CDC Trial Manager and get a life-changing career! This role is based in Istanbul, Türkiye, and directly reports to Therapeutic Area Head, Rare Disease.

The position

As CDC Trial Manager , you will be responsible for all deliverables on assigned clinical trials within the CDC including strategy, feasibility, recruitment, retention, risk analysis and management, database lock (DBL) and archiving, and responsible for achieving deliverables within agreed timelines and quality measures. You will be managing the CDC project team, including CRAs and CTAs, that support assigned clinical trials. Besides you will be also responsible for budgets, timeline, quality and risk in the start-up phase of the trial, proactively identifying any risks in start-up and site activation plans and developing and implementing mitigation strategies as required and representing CDC countries in study meetings, as relevant.

Your other responsibilities will be to

• Project management of assigned clinical trials within the CDC country and adjacent affiliates, responsible for project planning, management, and execution from site selection to post-clinical trial activities
• Liaise with the regulatory colleagues and country operations colleagues to agree on submission strategy to Health Authorities and Ethic Committees
• Provide operational and therapeutic expertise to the project and provide Global Teams with local intelligence
• Oversight and compliance check of e-TMF for assigned clinical trials in close collaboration with CDC CTA and track site trainings through CRA responsible
• Oversee the set-up of internal clinical systems and ensure COSMOS set-up and update at country level (for adjacent affiliates)

The Qualifications

You have bachelor level Life Science education with proven success in managing clinical trials (desirable), including multi-centre studies. You have excellent command over both written and spoken English. Having an experience in more than one phase of development and international trial coordination is desirable. You should also have;

• Ability to communicate with impact, and build and maintain strong relationships with internal and external stakeholders across organisational levels
• Project and resource management skills and ability to deliver quality in a timely manner
• Understanding of clinical trial regulations across Europe
• Excellent knowledge of clinical trial methodology and knowledge of drug development process
• Up to date knowledge of the clinical trials environment - ICH GCP, regulatory issues, SOPs
• GCP training attended and certified
• Computer literacy and IT skills including CTMS, EDC, COSMOS, and Veeva Vault

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 90 employees as TAs team members, Clinical Operations Excellence team members and start up team members

 

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 63,400 employees. Together, we go further. Together, we’re life changing.

Contact

To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).

Deadline

Apply before 17 July 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.