Major Responsibilities

• Assists COM/ACOM/SSU Lead to develop and coordinate to manage the study budget, accruals and actual cost, coordinate with CTA & CRA ensures study payments are paid on time
  

• Assists COM/ACOM/SSU Lead to develop study documents and other materials
• Coordinates vendor selection (CRO, translation, printing, travel agency, etc.) and management
• Supports TMF related work both paper and electronic Trial Master Files (eTMF) and study SharePoint, conducts eTMF QC if needed
• Supports PFDA document filing, CDE posting, CHGRAO submission, and ensures required documents are submitted to relevant functions/websites
• Assists COM/ACOM/SSU Lead to organize study team meetings, including meeting room booking and setup, meeting minutes taken is required; Provides enough logistic support for investigator meetings

• Coordinates with Clinical Supply Chain regarding drug forecasting and supply
  

• Coordinates with various system account apply and management
• Prepares and maintains various study tracker/metrics

Qualification

• Bachelor’s level degree or above in life sciences, English and management

• Fluent in English (listening, writing)

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

• 3 years (PMA), 5 years or above (Sr. PMA) of CTA/PMA or clinical trial experience in the Pharmaceutical or CRO industry

• Excellent communication and interpersonal skills

上班地址：上海市静安区延安中路1228号嘉里中心3座