Accountabilities

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 BI SOP (Standard Operation Procedure);

· Process stamping & signature request from BJ (Beijing) CO;

· Process other logistics support request from CO team;

· Process central safety distribution and query (including the Management of SAE (Safety Adverse

· Event) query mailbox) per local process;

· Process clinical study site payments and third party vendor payment application;

· Support IMP (Investigational Medicinal Product) importation document preparation;

· Compliance with the applicable regulations, SOPs, LWIs (Local Working Instructions) and local procedures

· Timing - Process request based on the agreed timeline

Central System Support

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

· Track BI China 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;

· - Timing - Process request based on the agreed timeline

· - Timing - deliver required reports / system data on time with quality

Clinical Study Support

· Assist CO team with in-house activities and documentation associated with the set up and managementof trial activities to ensure the successful and timely completion of all cli nical 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 BICTMS (BI Clinical Trial

· Management System) on behalf of Clinical Trial Manager and run reports accordingly;

· Resolve COPI (Clinical Operations Process & Information) reports (BICTMS, Clinergize);

· Creation of shopping carts and management of Pos (Purchase Orders) (includes related CO payments);

· Assist Study Manager track study & site payment / payments refund /expenses /invoice/ accrual;

· Maintain the current sponsor contact list and the trial/trial country specific trackers if applicable;

· Develop study materials template: Newsletter, local communication letter, etc.;

· Assist study team with study documents (such as country level ethics correspondence) collecting, uploading and maintenance and support study manager work with TDS (Trial Documentation Service) or TRS (TMF

· Records Specialist) about trial events to trigger document collections and follow up TMF issue;

· Support study routine meeting, taking meeting minutes (then sending for filing in TMF) and follow-up on the action items after meetings; as required;

· Co-ordinate closeout documents with CRA in preparation of close out visit;

· Co-ordinate the collection & retrieve & destruct old equipment when the study closes out;

· Other support from CRA during the COV (Close-Out Visit) (e.g., resolve document queries before Clinergize acceptance);

· Upload contract to CoRA (Contract Management Administration and Control) and TMF and tracking contract status.

· Maintain and archive all original contracts (Confidential Disclosure Agreement, Clinical Trial Agreement, CRO (Clinical Research Organization) work orders, etc.);



Minimum Education/Degree Requirements*

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

preferred



Required Capabilities (Skills, Experience, Competencies)*

? Good organizational and communication skill

? Well understand Good Clinical Practice, ICH-GCP

? Good in written English & fluent in oral English

? 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