Study Management Specialist

Purpose

Manage and Lead a project on all aspects of design, planning, startup, conduct, analysis,

reporting and closeout of assigned NIS including regulatory PMOS, IIS and PAA. Responsible for managing planning, timelines, milestone, budget, study sites, vendors and deliverables while maintaining quality and compliance.

Responsibilities

• Provide comprehensive input to study concept development especially operational point of view

• Develop study protocol/protocol amendment and CRF and get approval from GUS-RC or ARC and MFDS(if applicable) by managing multidisciplinary assessment.

• Develop and provide official answers to MFDS by collecting and analyzing reference/data regarding supplementary comments from MFDS (protocol, annual report, re-examination report) for regulatory PMOS

• Review and finalize CSR according to SOP and local regulation by coordinating and complying with a...