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CRA Manager

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2015.07.17.
Jelentkezési határidő: 2015.07.29.
Hirdetés azonosító: 931371
lejárt

 

 
 
CRA Manager
Our client is a global ethical pharmaceutical company with robust innovative development pipeline. We are seeking a CRA Manager to head up their CRA team and manage clinical site monitoring activities in Hungary.

Responsibilities:

Train & supervise team of CRAs and allocate trials according to local organization.

Assure that required level of knowledge and skill is present and that trial sites are monitored as per SOPs and monitoring plan, Identify skills & competency gaps.

Manage and direct the CRAs with problem solving where needed.

Work with global training team to develop training plans and coordinate training as needed.

Develop local affiliate by identifying and screening new sites for participation in assigned trials.

Ensure that prevailing legislation, GCP and SOP requirements are fulfilled.

Maintain professional, quality focused, local SOP system.

Coordinate preparation for audits & inspections.

Set objectives for CRAs and review the performance regularly.

Talent development.

Conduct regular co-monitoring visits with CRAs.

Review Monitoring visits reports, provide feed back and follow corrections.

Requirements:

University degree in Life Sciences / medical / pharmaceutical discipline

Demonstrable experience in Clinical Operations preferably in line management or study management role

Proven track record in clinical site monitoring

GCP knowledge

Highly developed communication skills and can-do attitude
 
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