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• 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