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A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
• 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
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com