Responsibilities:

Complex laboratory support for clinical trials projects:

• Administrative management: Planning, conducting and documenting of project-related activities, development of Clinical trial related documentation:

a) trial specific Analytical plan;

b) laboratory Manual;

c) Laboratory tests schemes, laboratory materials forms, assays reference ranges;

d) harmonization etc.

• Laboratory management:

1 Laboratory samples receipt in the laboratory, registration in LIS;

2 Freezing, storage, tracking, inventory of lab. samples;

3 Biosamples and documentation quality control;

4 Coordination of laboratories in different cities/countries in the frame of one project,

5 Laboratory reports validation,

Interaction with Investigating sites on various issues.

6 Samples preparation for dispatch to various countries

7 Work with delivery companies: DHL, FedEx.

8 Preparation of laboratory equipment for laboratory analyses.

Keeping different trackers and registers.

• Technical management: Technical support for projects generation in laboratory informational systems, databases, data entering

implementation of GCP and GCLP requirements for all CT participants.