Clinical Research Associate / Монитор клинических исследований

☑ Основной блок:

Опыт работы: 1–3 года.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 21724440 добавлено в базу данных: Четверг, 6 февраля 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Репутация компании "ООО Ново Нордиск":

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☑ Подробности о вакантном месте:

Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases.

Headquartered in Denmark, Novo Nordisk employs over 43,000 people in 80 countries, and markets its products in more than 170 countries.

Our history in Russia can be traced to 1924 and with the recently (2018) completed expansion of our greenfield and wholly owned modern insulin manufacturing facility in Kaluga now we are proud more than ever of our commitment to Changing Diabetes® for the 10 million people with diabetes in Russia.

We are launching new products, making them more accessible to patients, and we also see ambitious government healthcare plans (National Projects) that are aligned with our own long-term commitments through Changing Diabetes® and Changing Obesity®.

For the future, we have set ambitious plan to deliver strong growth, which builds on our success and emphasizes critical components of performance: leadership and outperforming the competition. It is therefore a pleasure to announce the creation of new frontline focused positions, to increase our share of voice and coverage.

The position

As the Clinical Research Associate you will be the primary point of contact between site staff and Novo Nordisk, you will act as an ambassador for the company. You will be responsible for monitoring of the study at sites in compliance with local regulations, ICH-GCP, NN procedures and protocol requirements to ensure data quality and study subject protection, as well as for recruitment at site level. At this role, you will deliver results that have a direct impact on the successful completion of the clinical program.

Main responsibilities also include:

• Prepare trial documents for submission to Regulatory Authorities;
• Perform sites feasibility and investigators’ selection;
• Communicate with sites for ensuring adequate enrolment rate;
• Perform clinical on-site monitoring activities (source data verification and review, drug accountability, data collection etc.);
• Support audit and inspections at sites as applicable;
• Prepare and submit Monitoring Visit Reports within defined timelines;
• Maintain and update study related documentation from CRA's area responsibility;
• Manage and complete reporting of Serious Adverse Events happened within Clinical Trials on site;
• Provide study related training for Investigators on the routing practice;
• Proactive use of electronic data capture system (EDC) for preparation and conduct of site visits as well as source data verification in collaboration with data management.

Qualifications

• You hold University degree (life science or medical/pharmaceutical preferred).
• Experience in on-site monitoring is preferred, however, other relevant experiences and skills may be considered when considering the candidate’s eligibility.
• Your experience in local study management will be a strong advantage.
• Knowledge of GCP and local laws and regulations for clinical trials is preffered.
• Computer literacy (e.g. EDC, IMPACT, MS Office, etc.).
• Excellent verbal and written communication skills in English.
• Willing and able to travel.

On a personal level, you have good at planning, coordinating & prioritizing activities in order to ensure optimal use of resources in the department, as well as good negotiation, communication & collaboration skills.

You are able to relate to people in a diverse & international environment, to handle numerous tasks simultaneously.

You have analytical type of thinking, attention to details and easy learning skills.

You demonstrate quick problem-solving capability and ability to work in stressful situations.

You are also able to be initiative, innovative and proactive, to work independently and as a part of the team

About the department

Clinical department of Novo Nordisk in Russia conducting clinical trials II-IV phases according to Good Clinical Practice and local regulatory requirements.

Working at Novo Nordisk

At Novo Nordisk we recognise 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 the communities we operate in.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

☑ О компании:

Сфера деятельности компании: Медицина, фармацевтика, аптеки; .

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