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  2016-11-08 16:30 972

̱ ӻ START-UP ãϴ.


PERFORMANCE & COMPLIANCE
Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.

COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.

MANAGEMENT & QUALITY OVERSIGHT
Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. Oversees CTCs as applicable. 

COLLABORATION
Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and  local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.

LOCAL PROCESS OVERSIGHT
Oversight and coordination of local processes. Clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.


ӻ 5~9


   :
   ó: 02-6925-5391
   ̸: ds@hrfind.co.kr