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 appropriate
• Proficient in using Merck China specific financial tools / systems to create accurate financial documents
• Responsible for invoice processing and tracking in a timely manner
• Ensure all financial documentation is audit ready for inspection at all times
• Knowledge and usage of databases and programs of the department
• Support CTLs/CRMs for surveillance of Merck compliance in trials/programs
• Review the Clinical Trial Management Systems for any relevant details required
• Ensure in conjunction with the CTLs/CRMs that all systems are updated on a regular basis
• Communicate with CRO or other functions accordingly to ensure TMF inspection readiness at all times
• Perform electronic or paper TMF vendor surveillance as appropriate, including those in Chinese local language
• Coordinate 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 requirement
• Prepare and coordinate the process for the creation of legal documents for clinical trials/programs, e.g. Power of Attorney
• Ensure 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 CRO
• Support CTLs/ CRMs / Trial Teams/ COT in trial medication activities, if required
• Support 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 consult
• Support 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 process
• Develop and maintain complex administrative systems / reports and formats
• Assist in the development of and/or delivery of presentations, as requested
• Organize meetings that are not under the responsibility of the CRO, as required
• Assist the CTLs/ CRMs/ Trial Teams/ COT in preparation of Audits or Inspections and participate in Audit and Inspection interviews, as required
• Drive/Coordinate the set-up and follow-up of Corrective and Preventive Action Plans (CAPAs) associated with Audits, as requested
• Prepare and hold presentations for training sessions, line managers meetings, department meetings, program or trial meetings as required
• Demonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledge
• Make process improvement suggestions and develop new process approaches
• Contribute to training and provision of direction and guidance to increase knowledge of new team members / new employees
• Ensure harmonization of processes throughout Global Clinical Operations
• Participate in indication- or program-specific trainings
• Contribute 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 China
• Act 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 Global
• Take on additional tasks as assigned by management