Архив. Country Study Specialist

This is a permanent, full-time role at Roche, Global Healthcare Company for experienced CRA seeking development in the project management and team leading areas.

Main Qualification

Ø  University degree, preferably in a medical field;

Ø  Previous job experience demonstrating knowledge and understanding of clinical trials; 

Ø    Experience in Multiple sclerosis is desirable;

Ø  Previous experience managing projects and clinical trials monitoring is desirable;

Ø  Able to prioritize and manage multiple tasks with high flexibility;

Ø  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;

Ø  Fluent in written and spoken Ukrainian, Russian and English

Ø  Ability to work independently under limited supervision;

Ø  Readiness to travel domestically and abroad, if necessary;

 Main responsibilities:

Ø  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 starting from the trial initiation till the data base lock, ensuring the Roche quality and safety standards of ongoing trials, as well as compliance with applicable regulatory requirements, time frames, budgetary commitments.

·       Perform/ coordinate activities on assessment of possibilities of the trial conduct at the level of the trial and investigative sites, including assessment of the patients population and final site selection (if applicable).

·       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’ start-up meetings, if such participation is approved in accordance with the Company Travel Policy; Participation in local purchase of necessary equipment/ medications, if required by the Trial Protocol;  Negotiations with investigative sites and investigators on agreements execution; Work with the Shared Investigator Platform; Conduct of motivation visits to investigative sites. 

·       Ensure effective continuous communication between all parties.

Ø  Supervise clinical trials conduct by local teams to ensure effective trials management:

·       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 in accordance with the Agreement.

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

·       Be responsible for coordination and supervision of fulfillment of actions developed as a part of the trial audit/ inspection in the local affiliated person.