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.

上班地址：金地中心B座