Clinical Trial Administrator-FSP

Clinical Study Support

- Assist CO team with in-house activities and documentation associated with the set up and management of trial activities to ensure the successful and timely completion of all clinical trial milestones;

- Co-ordinate translations of documents after review/translation (approvals, applications, advertising, patient materials, ICFs (Informed Consent Forms) etc.)and submit for TMF (Trial Master File) filing;

- Support CRA (Clinical Research Assistant) to prepare the safety information submission per site specific requirement;

- Create and update the ISF (Investigator Site File) (including paper ISF and binders);

- Support study routine supplies purchase (including printing documents), distribution, calibration validity of loaned equipment;

- Assist in organization & execution of investigator meeting;

- Maintain study information (event dates, feasibility information, IND (Investigational New Drug) application and approval date etc.) in CTMS (Clinical Trial Management System) on behalf of Clinical Trial Manager and run reports accordingly;

Central Administrative Support

- Provide logistic support, organization to CO internal& external meetings, trainings;

- Provide administrative support to clinical trial insurance certificate application, annual review;

- Process clinical study document and CO operation document archiving request per Local OPU (Operation Unit) process;

- Process post study Financial Disclosure request per SOP (Standard Operation Procedure);

Central System Support

- Support Study Manager doing clinical trial information disclosure per local regulation;

- Track CO clinical trial local disclosure KPI (Key Performance Indicator);

- Act as system key user to process end user request, system demonstration to end user;

- Support Line Manager generate report and compliance check；

Requirement：

-Bachelor degree, Major in nursing, pharmaceutical or other bio-science related area is preferred；

- Good organizational and communication skill

- Well understand Good Clinical Practice, ICH-GCP

- well command of Microsoft Office applications

- Ability to work as a team and backup team members

- Minimum 1 years working experience in pharma industry or other related industry

experience is preferred