от компании (организации): Coleman Group в городе (населённом пункте): Москва, Россия
в отрасли экономики "Производство, сельское хозяйство" → "Главный инженер"
с заработной платой: по договоренности
Вакансия № 29597246 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 4 ноября 2024 года.
Дата обновления вакансии № 29597246 на сайте Работа в Москве и Московской области (МО, Подмосковье): Четверг, 14 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 29597246 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Clinical Research Manager for Medicines and Medical Devices
Responsibilities:
- Support of all issues related to clinical trials of medicines and medical devices for the purposes of registration under the EAEU procedure and the national procedure (OTC drugs, condoms, lubricants)
- Preparation of responses to the regulator's requests (if necessary), preparation of a package of documents for registration purposes (concerning the clinical part of the dossier)
- Interaction with regulatory authorities (Roszdravnadzor, Ministry of Health), with organizations conducting clinical trials, with a local team, with global colleagues
- Selection of contractors for conducting DKI and CI;
- Preparation of technical specifications, collection, analysis of data from contractors, provision of information for selection, conclusion of contracts, control of payments;
- Monitoring the progress of research: quality, deadlines, documents provided for the regulatory dossier, communication with contract research organizations and other service providers (laboratories, logistics), application of corrective measures if necessary;
- Organization of the process of preparing a package of documentation for submission to the Ministry of Health of the Russian Federation and the Russian Health Service in order to obtain permission to conduct a clinical trial;
- Preparation and justification of the research budget; cost control according to the approved budget.
Requirements:
- Higher education: medical, pharmaceutical, biological, chemical education;
- Work experience – from 1-2 years in CRO as a clinical research monitor/ manager/ quality specialist or in international pharmaceutical companies as a manager/clinical research specialist.
- Experience in supporting clinical trials of medicines and medical devices;
- Knowledge of the regulatory framework for the registration of medicines and medical devices in Russia and in the EAEU (as an advantage);
- Knowledge of the principles of CRO operation;
- Availability of certificates in the field of GCP;
- Knowledge of Decisions of the EEC Council regarding clinical trials of medicines and medical devices;
- English is upper-intermediate and higher.
Conditions:
- Competitive salary;
- Medical insurance;
- Hybrid work format;
- The Company's office is located within walking distance from Paveletskaya metro station
Откликнуться на эту вакансию: Clinical Research Manager for Medicines and Medical Devices
Предыдущая вакансия:
Вакансия № 29597233 на должность Ассистент руководителя от компании Control by Energy в городе (населенном пункте) Москва