北京招聘

  

 

  

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

          

 

  

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。