Clinical Trial Assistant

该职位来源于猎聘 Key Accountabilities:Support CTLs / CRMs / Trial Teams/ COT for budget management under own responsibility, budget forecast as well as for building accruals as appropriateProficient in using Merck China specific financial tools / systems to create accurate financial documentsResponsible for invoice processing and tracking in a timely mannerEnsure all financial documentation is audit ready for inspection at all timesKnowledge and usage of databases and programs of the departmentSupport CTLs/CRMs for surveillance of Merck compliance in trials/programsReview the Clinical Trial Management Systems for any relevant details requiredEnsure in conjunction with the CTLs/CRMs that all systems are updated on a regular basisCommunicate with CRO or other functions accordingly to ensure TMF inspection readiness at all timesPerform electronic or paper TMF vendor surveillance as appropriate, including those in Chinese local languageCoordinate long-term ISF (Investigator Site File) document storage at site(s) per China GCP requirement to designated archiving vendor(s) for long term storage per Merck requirementPrepare and coordinate the process for the creation of legal documents for clinical trials/programs, e.g. Power of AttorneyEnsure together with CTLs / CRMs / Trial Teams/ COT that risk management for the corresponding trials / programs is established and updated on an ongoing basis together with the CROSupport CTLs/ CRMs / Trial Teams/ COT in trial medication activities, if requiredSupport CTLs/ CRMs / Trial Teams/ COT with special activities for vendor surveillance.Ensure all trackers are maintained in an up to date manner and available for the CTLs/ CRMs / Trial Teams/ COT to consultSupport CTLs/CRMs for Investigator Meetings, as applicable. Ensure correct code of practice / compliance is adhered to by the CRO and relevant information is provided to assist this processDevelop and maintain complex administrative systems / reports and formatsAssist in the development of and/or delivery of presentations, as requestedOrganize meetings that are not under the responsibility of the CRO, as requiredAssist the CTLs/ CRMs/ Trial Teams/ COT in preparation of Audits or Inspections and participate in Audit and Inspection interviews, as requiredDrive/Coordinate the set-up and follow-up of Corrective and Preventive Action Plans (CAPAs) associated with Audits, as requestedPrepare and hold presentations for training sessions, line managers meetings, department meetings, program or trial meetings as requiredDemonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledgeMake process improvement suggestions and develop new process approachesContribute to training and provision of direction and guidance to increase knowledge of new team members / new employeesEnsure harmonization of processes throughout Global Clinical OperationsParticipate in indication- or program-specific trainingsContribute to workshops / special initiatives as expert/ professional for dedicated topics, including those involve innovation and new technology such as AI (Artificial Intelligence) solutions in optimizing clinical study start-up and conduct in ChinaAct as point of contact at Merck China to selected machine AI translation vendor and perform post-edits or QCs for certain clinical operations documents as assigned, maintain the memory database and translation accounts for Merck China or beyond to GlobalTake on additional tasks as assigned by management