Clinical Trial Administrator

Уровень зарплаты
Город
Требуемый опыт работы
з/п не указана
Новосибирск
1–3 года

Project work, min 1 year

Job location:

Are you ready to make the next step in your professional development in global expanding company? Join Novo Nordisk region AAMEO BACIS and get a life-changing career!

Region AAMEO (Africa, Asia, Middle East, and Oceania) is one of the main drivers of Novo Nordisk’s growth today, covering 110 countries in Africa, Asia, Middle East, Russia & Oceania, employing 4,605 people. Novo Nordisk is the world leader in diabetes care and a significant leader in haemostasis management, growth hormone therapy and hormone replacement therapy.

BA CIS (Business Area of Commonwealth of Independent States), a part of AAMEO, is a vast region that includes 10 countries from the CIS plus Mongolia, with 320 employees. The local manufacturing facilities for modern insulin started operating in April 2015 in the Kaluga region Russia.

About the department:

Clinical research is an area within Clinical & Medical & Regulatory function, responsible for delivering fast and high quality clinical data to support research & development portfolio of Novo Nordisk products in Russia.

You will join a team of more than 40 highly skilled Clinical Trial Administrators, Clinical Research Associates and Project Managers. You will be located at Novosibirsk office facility.

The position:

In your role as CTA you will be an essential member of the trial team, and has a significant role in conducting trial related tasks in a proactive and independent manner. You will assist in all relevant aspects of trial preparation, execution and finalisation in order to facilitate the process towards timely clinical project deliverables of required quality. You will be responsible for the set-up and maintenance of Trial Master File tasks according to NN SOPs (Country and Site specific documents); prepare and distribute bio-samples export documents packages to the sites; make translations of trial related documents (from English into Russian and vice versa).

Qualifications:

  • You hold a University degree or any other relevant education
  • Minimum 1 year of an administrative experience
  • You have the team oriented personality
  • Quality mind-set with attention to details
  • You have the ability to analyze data; good communication skills
  • You are flexible and result-oriented with a ‘can-do’ attitude, able to adjust quickly to new situations in a continuously changing business environment
  • Good command of Russian and English oral and written would be a great advantage. Knowledge of medical/pharmaceutical terminology will be a plus.
  • Knowledge of relevant clinical IT systems, i.e. eTMF, databases created locally (e.g. «IRB_LEC_data base_CEC_Moscow.xls», «IRB_LEC_data base_Central.xls», «IRB_LEC_data base_Nord-West.xls», «IRB_LEC_data base_Ural-Siberia.xls»; «Investigators data base») will be an advantage.

Working at Novo Nordisk:

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Тип занятости

Полная занятость, полный день
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