Payment is negotiable
Major generic company is looking for a staff specialist, with experience more than 2 years in clinical trials. Work without travel. Oversee CRO organizations.
- Interaction with organizations involved in project implementation (contract research organizations, research centers, analytical and Central laboratory, transportation and warehousing organizations) on issues of workflow, training, document archiving of preclinical and clinical trials and agreements on the projects;
- Preparation and participation in the organization initiating interim and closing visits to research centers;
- Preparation of documents and staff research centers to audit, auditing support;
- administrative and financial issues with suppliers, logistical support requests, monitoring performance;
- Interaction with research centres on the preparation of protocols and reports for studies within the framework of their compliance with current legal and methodological requirements of MOH of the Russian Federation;
- Preparation of summary report of preclinical and clinical stage drug development;
- conformity Assessment Protocol and data integrity;
- participation in the trainings for the clinical centers, quality control of their performance;
- control over the execution of obligations by contractors in accordance with the research plan and the technical specifications (terms, control over spending of the budget, the correctness of the documentation, the implementation of the plan of monitoring visits), and compliance procedures of the study to the rules of good faith (qualitative) clinical and/or laboratory practices;
- Comonitoring and audit clinical sites and contractors;
- quality Control of accounting and reporting documents;
- the Formation of a master file drug (DMF);
- Formation of master file research (TMF);
- the Formation of M2, M4 and M5 CTD;
- document Archiving.
- Education higher medical / biological;
- Courses in biostatistics, rules for the conduct of preclinical and clinical trials of medicinal products;
- Experience in clinical and/or preclinical studies from 3 years.
- Knowledge of Russian and international legal documents regulating pre-clinical and clinical research; ICH GLP and ICH GCP, CONSORT Group Statement, OECD, EEU;
- Skill scientific editing and correction;
- Knowledge of statistical methods of analysis, ability of practical application of biostatistics;
- advanced PC user (MS Offiсe; Power Point, StatSoft);
- English language – working level (working with documentation; business correspondence; negotiations).
- understanding of the principles and methodology of preclinical and clinical studies, understanding of the process of drug development, knowledge of clinical pharmacology, the knowledge of the structure and document requirements of sections M2, M4 and M5 ICH CTD, a clear understanding of the structure of DMF and TMF, knowledge, and leadership rules of GLP and ICH GCP, GVP.
- High working efficiency, diligence, punctuality, diligence; ability to negotiate, to speak before an audience, self-organization, diligence, erudition, ability to self-education, a high level of literacy.
- Salary based on interview results
- LCA life insurance
- Power in the office
- Mobile communications
- Corporate training
- Opportunities for professional, career and material growth