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 company’s 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;

Central System Support

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

• Track 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;

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);

• 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, IND (Investigational New Drug) application and approval date etc.) in TEAMCTMS (TEAM Clinical Trial Management System) on behalf of Clinical Trial Manager and run reports accordingly;

• Resolve COPI (Clinical Operations Process & Information) reports (TEAMCTMS, Clinkerwise);

• 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 RA (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.);

• Team may support NMPA (National Medical Products Administration) inspection and self-check activity,

• Audits and CAPAs (Corrective Action Preventive Action) per business needs;
Related performance indicators

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

• Timing - Process request based on the agreed timeline

• Timing - Process request based on the agreed timeline

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

• Quality - Positive feedback from project managers, key stakeholders

• Compliance with the applicable regulations, SOPs, WIs (Working Instructions) and local procedures

• Timing - Process request based on the agreed timeline

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

• Quality - Positive feedback from project managers, key stakeholders
Minimum Education/Degree Requirements*

• Bachelor degree, Major in nursing, pharmaceutical or other science related area is preferred

• Required (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

• work as a team and backup team members

• Minimum 1 years working experience in pharma industry or other related industry experience is preferred

其他信息
语言要求：英语、普通话
行业要求：全部行业