Mgr, Process Delivery - Quintiles Transnational

Mgr, Process Delivery 
Quintiles Transnational - Bangalore, Karnataka

PURPOSE:

• As a member of the Site Visit Report Reviewer (SVRR) management team, one‘s focus is on quality, subject safety, data integrity and regulatory compliance. 

• The SVRR Line Manager (LM) will support the SVRR Lead and the team to deliver efficient and effective review of Site Visit Reports (SVRs) and its associated attachments in compliance with Quintiles SOP, ICH/ GCP guidelines, and protocol requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES: 

• A minimum of at least 2 years of management experience within Quintiles or an equivalent. 
•  Previous experience as a CRA/CRS/CPM is preferred. 
•  In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. 
•  Excellent knowledge and understanding of the clinical monitoring processes and sound knowledge of clinical trial systems and applications (CTMS and InnTrax).

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