eTMF Process Manager (m/w/d)

As a specialist in digestive and metabolic medicine and family businesses with global networking, we focus on the development and distribution of innovative medicines for various diseases of the liver, the bile ducts, the intestine and the esophagus to improve human life. We believe that we can only achieve medical progress together. So we are looking for: They support the eTMF Process Manager with the support and further development of the electronic Trial Master File System (Veeva Vault eTMF) and all related processes, including: Implementation of new regulatory and internal requirements in close cooperation with users, IT and the software provider Assessment of the need for updates and execution of the associated change control management taking into account the requirements in the GxP environment Analysis, Optimization and Modelling of Business Processes (Continuous Process Improvement) Standardization of procedures by creating manuals, designation conventions, SOPs, training documents Implementation of user training User support in the application of the software System Administration of Veeva eTMF Active networking with interface functions such as individual clinical research teams and IT

University degree, preferably in the field of natural sciences and/or computer science Experience with electronic document management with focus on eTMF Experience in Clinical Trial Management First experience in project management First experience or willingness to develop External Vendor Management (CROs and Software Providers) Knowledge of regulatory requirements in the pharmaceutical field and the GxP guidelines Knowledge or willingness to develop knowledge in the field of computer system validation (CSV) Outstanding analytical and conceptual skills Structured working and the ability to work independently Embossed communication skills and connected thinking Very good knowledge of German and English in word and writing

New Work, flexible working hours and mobile work Various benefits such as Hansefit, Jobrad, Germanyticket, kindergarten grant and purchase of additional holiday days Comprehensive onboarding and mentoring program Individual training opportunities International and growing family business with short decision-making and financial independence For questions, Sabine Aicher is available by e-mail at personal@drfalkpharma.de or by telephone 0761 1514-253 (Monday to Thursday). We look forward to your application via our online portal. JOBV1_EN