Clinic Trials Coordination – Manager

Активная вакансия кадрового агенства «Аспект»

от 125000 рублей

Обязанности

- Ensure the assigned and accepted projects of BioEquivalence (BE) / Clinical Trials (CT) - completed successfully with in the time line.

- Identifying good Clinical Research Organisation companies / Negotiation / Follow ups & Management of Projects assigned to the Clinical Research Organisation companies / complete the project with in the targeted time line.

- Developing contacts with Key officials in Ministry Of Health & updating the Russian regulatory guidelines time to time.

- Designing of study protocol for products & get approvals from Ministry Of Health.

- Selection of BE / CT centres and developing contact with key persons.

- Selection & Coordination with investigators who is qualified by training and experience to monitor the progress of the investigation.

- Following up and ensuring the investigation & clinical trial is conducted in accordance with the general investigational plan, protocols, Standard Operational Procedures’, ICH-GCP guidelines.

- Follow up and monitor the progress of all clinical investigations being conducted and ensure completing as per time line targeted.

- Reviewing and evaluating - relating to the safety and effectiveness of the drug as it is obtained from the investigator.

- Maintaining and retaining adequate records and reports.

- Regular visit to Research centres to monitor, verify and ensure correct filling of Case report forms.

Требования

- Graduate of Medicine (preferred) or post Graduate of Pharmacology + Post Graduate Diploma of Business Management in clinical trial (two years full certificate course or Diploma course conducting clinical trials).

- To 5 years of experience in monitoring, planning of clinical trial as an sponsor representative or investigators

- Must be aware about the Russia guidance of clinical trial

- Having good pharmacology and medical expertise to understand:

variability of the drug;

variability due to dosage form;

safety aspects;

statistics Ratio.

- Must aware about the safety rules regulation and insurance law

- Must be aware about International Conference Harmonization (ICH) Good Clinical Practice (GCP) № 6 guidelines.

- Excellent communication skills.

- Project management skills.

- Negotiation skills.

Условия

Representation of a foreign company (manufacture and sale of pharmaceuticals and medical devices).

- Office is in walking distance from the subway (7 min. Walk).

- Hours of operation: Monday - Friday, from 09:00 to 18:00 hours.

- Salary: salary of 125,000 rubles. (Gross) + payment mob. communication 500 rubles. + Travel costs 3,000 rubles. + Company car + medical insurance.

- Making according to LC RF.

Контакты

Евгения

Тел. +7(915)451-6749; 545-2172 (многоканальный)

Е-mail: job4@jobaspect.ru

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