Clinic Trials Coordination – Manager
Активная вакансия кадрового агенства «Аспект»от 125000 рублей
- 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.
- 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;
- 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.
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.
Тел. +7(915)451-6749; 545-2172 (многоканальный)