北京招聘

Responsibilities:
1. Responsible for study documents filing, tracking and archiving and ensure these activities performed in compliance with GCP/SOPs and local regulation. 
2. Responsible for study administrative supports in compliance with according company policy and local regulation.
3. Providing general administrative supports to CRAs and line manager. 
4. Establish and maintain sound working relationships with external (supplies, agency) and internal customers (finance, IT) to provide required supports to clinical trials. 
5. This role should understand company's compliance and SHE policy, and to manage the daily activity to align with these accordingly.
6.Responsible for well managing eTMF and paper TMF of sponsored & Externally sponsored study. (if needed) Champion of eTMF system.

Qualifications:
1. Bachelor degree or above.
2. Majored on Medical/pharmacological/Nursing/Science is desirable.
3. Understand GCP, ICH GCP, HGR regulation. Good sense of this regulation.
4. 1~2 years experience as CTA/CPA/CTC is preferred.
5. Clinical Research experience on multinational pharma or CROs is a plus.
6. Fluent English in reading, writing and speaking.
7. Good communication skill, teamwork spirit, able to learn and adapt to IT system and scan equipment.

德琪医药有限公司（简称“德琪医药”，香港联交所股票代码：6996. HK）是一家专注于创新抗肿瘤药物的亚太地区临床阶段生物制药公司，德琪医药旨在为亚太地区及全球各地的患者提供全新作用机制的抗肿瘤创新疗法。自成立以来，德琪医药已建立起拥有12款临床及临床前创新药物的丰富产品管线，取得9个临床批件，并在亚太地区开展9项跨区域临床试验。公司在研产品专注于创新的靶点或作用机制，并拥有成为同类首款潜力的药物。德琪人以“医者无疆，创新永续”为愿景，力争通过对全球***和同类最优的专研与市场化，解决亚太乃至全球患者未满足的临床需求。