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Local Trial Manager

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2013.07.11.
Jelentkezési határidő: 2014.02.25.
Hirdetés azonosító: 597673


Local Trial Manager
Local Trial Manager position has arisen at our global pharmaceutical partner in Hungary. Our assignor is a global leader in research and development of pharmaceuticals. We are seeking an achieved clinical research professional to join their world class operation which is an inspiring environment with continuous development opportunities.

The local study manager is accountable for planning, executing and reporting on a number of phase I-III, global phase IV and TM clinical studies for Hungary, from planning and site feasibility through study close-out, in compliance with processes and regulatory requirements.
This position is key to good communication and professional relationships with clinical investigators and international colleagues in HQs.

Major Accountabilities:

Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel
Provide training as needed for monitors and any other activities that support site readiness to recruit.
Drive the conduct of the trial, track and oversee progress and status.
Accountable for coordinating data management activities through the local trial team.
Ensure that all trial close–out activities are performed, in close cooperation with field monitors and clinical trial head.
Support trial feasibility and patient commitments in cooperation with the relevant line units
Coordinates and manages the site selection process in collaboration with the necessary line units
Ensure all operational aspects are on schedule.
Perform co-monitoring visits and review site reports

Required skills and expertise:

5 years+ experience in clinical research including previous experience as Clinical Research Associate
at least one year experience in clinical project management: perform co-monitoring visits and review site reports of CRAs
Life Sciences degree preferred

Please send your CV in English to the attention of Ivan Harmath.

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