Clinical Trail Coordinator-Beijing

Posted 21 Mar 2019

Beijing - all, Beijing - China

Req Id 187616


我们的 51000 名员工正塑造着全球的生活、工作和娱乐方式,通过下一代医疗保健、生命科学与高性能材料领域中的进步。350 多年来,横跨全世界,我们热切地追求我们的好奇心,以便找到创新和充满活力的方式来改善他人的生活。


• Support CTLs/ Studies/Clinical Operation Team for budget management under own responsibility, budget forecast as well as for building accruals as appropriate

• Knowledge and usage of databases and programs of the department

• Proficient in using financial tools / systems and related functions to create accurate financial documents, as well as troubleshooting as required

• Support CTL for surveillance of Merck Serono Company compliance in studies/programs

• Responsible for the creation of purchase orders, receiving, and invoice processing

• Responsible for the review of invoices and obtaining CTL or delegate approval

• Responsible to ensure that payments are processed in a timely manner and are tracked

• Ensure all financial documentation is audit ready for inspection at all times

• Review the Clinical Trial Management//Infosario System for any relevant details required. Ensure in conjunction with the CTL that all systems are updated on a regular basis.

• Perform TMF vendor surveillance as appropriate. Communicate with CRO or other functions accordingly to ensure TMF inspection readiness at all times.

• Prepare and coordinate the process of legal documents for clinical trials, e.g. power of attorney

• Ensure together with CTL that risk management for the corresponding trials / programs is established and updated on an ongoing basis together with the CRO.

• Contribute to workshops / special initiatives as expert/ professional for dedicated topics

• Prepare and hold presentations for training sessions, line managers meetings, department meetings, program or trial meetings as required

• Support CTL / Studies/Clinical Operation Team with special activities for vendor surveillance.

• Develop and maintain complex administrative systems / reports and formats.

• Ensure all trackers are maintained in an up to date manner and available for the trial team(s) to consult

• Support CTL 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.

• Organize meetings that are not under the responsibility of the CRO, as required

• Assist in the development of and/or delivery of presentations, as requested

• In conjunction with the CRO, establish and maintain archiving according to ICH-GCP, company SOPs and WIs, as requested

• Assist the trial / Clinical Operation Team in preparation of Audits or Inspections

• Participate in Audit and Inspection interviews, as required

• Assist in the set up and follow up of Corrective and Preventive Action Plans (CAPAs) associated with Audits, as requested

• Demonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledge.

• Take on new assignments (if applicable: additional responsibilities from other roles within CTM must be assigned by the manager)

• Participate in Indication or program specific trainings



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