Архив. Country Study Specialist

This is a 1-year contract, full-time role to support demanding neurology projects Sponsored by Roche, Global Healthcare Company. This multiple-functional role will be excellent for experienced CRA seeking development in the project management and team leading areas.

Main Qualification

University degree, preferably in a medical/science-related field;
Previous job experience demonstrating knowledge and understanding of clinical trials; 
Previous experience managing projects and clinical trials monitoring;
Experience in neurology is desired;
Able to prioritize and manage multiple tasks with high flexibility;
Proved project management skills to work with a variety of different systems and databases/ prompt delivery of high quality results/ computer skills/ usage of MS Office software, web-systems;
Fluent in written and spoken Ukrainian, Russian and English
Ability to work independently under limited supervision;
Readiness to travel domestically and abroad, if necessary;
 

 Main responsibilities:

coordination of projects and taking operational decisions to support of Country Study Managers and supervision of clinical trials conduct by local teams to provide effective management of trials:

Coordinate/ provide operational support to perform activities as a part of clinical trials beginning from the trial start-up and during their active stage, ensuring the Roche quality and safety standards of ongoing trials, as well as compliance with applicable regulatory requirements, time frames, budgetary commitments.
 

Make an active contribution to strategies and actions on the trial initiation and patients enrollment to support effective trials management, including participation in investigators/monitors’ meetings, conducting recruitment booster/motivational visits and monitoring activities, if required;
 

Participation in local purchase of necessary equipment/ medications, if required by the Trial Protocol;  Negotiations with investigative sites and investigators on agreements execution;
 

Ensure achievement of recruitment goals, high level of investigators’ motivation and study conduction quality at the investigational sites.
 

Ensure effective continuous communication between all parties. Establish productive and positive communication with sites.
 

Support/ coordinate harmonization of investigative sites’ budgets in accordance with the Guidance on Fair Market Value and budget plans, as well as guarantee payments to investigative sites and vendors in accordance with agreements.
 

Ensure maintenance of the Trial Master File at the country level and its quality review (including translations, if applicable)
 

Deliver necessary operational support for the ongoing studies.