22.04.2021Merz AestheticsFrankfurt am MainClinical Outsourcing Expert (m/f/d)You ensure the overview of potential providers of clinical services (internal /external) and support the functions in clinical development in the preselection process
You are responsible for the management of proposals for clinical services of clinical development (request, evaluation, and negotiation of proposals) incl. until contract signature, set-up and maintenance of the purchase system Ariba
You support the selection and management of preferred and/or selected partners, including coordination of internal and external team meetings and ensuring internal approval processes and the documentation
You initiate and manage internal meetings with respect to outsourcing topics in Clinical Development
You perform the change order process in collaboration with the respective functions, as well as contract amendments and reconciliations
You improve outsourcing processes and update and review relevant SOPs
You ensure cross-functional collaboration within R&D AXUniversity degree in life sciences, medical health, business administration or qualifications equivalent to university degree
At least 3 years of experience as clinical outsourcing expert
At least 3 years of experience in outsourcing and negotiation processes of clinical trials
Experience in budget set-up and budget management of complete outsourced clinical trials
Significant knowledge in clinical study processes, roles and responsibilities of involved functions
Significant knowledge in clinical trial specifications for clinical trial tasks
Excellent interpersonal, communication and presentation skills
Profound English (written and spoken)
Preferably knowledge in relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.)
Excellent keyboard skills, with experience in using Microsoft Office (Word, Excel, Power Point, Outlook) applications
High flexibility, self-motivation and solution-orientation paired with high level of independence of working and self-initiative