Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process. Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. To support our clincal operations team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible. Clinical Study Administrator (gn) In this posiition you will carry full responsibility in supporting the clinical study team in all aspects of the clinical study management and coordination. This will include the following tasks: Support and/or lead assigned activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives Coordinate activities as it relates to development of clinical documents and other operational documents as appropriate as well as any updates/amendments to those documents Preparation, distribution and filing of meeting minutes Ensure timely entry and/or update appropriate information into tracking and communication tools, monitor study progress and proactively identify issues for resolution with the Clinical Study Manager Support and management of vendor selection process Support in IMP and study material supplies by liaising with service providers as appropriate Coordinate all activities and documentation related to patient insurances, site/investigator contracting and payment administration Organization of translations Generation and maintenance of templates and documents Support of formatting and finalizing documents Project specific filing of documentation Maintenance and Archiving of TMF Adherence to internal quality standards and workflow Technical training (MTA / BTA / CTA / comparable) or university degree in life sciences At least 2 years of relevant work experience Well-organized team player Problem-solving skills Attention to detail Good knowledge in MS Office Fluent in English, German knowledge preferable Flexible working time Hybrid work 30 days paid vacation Formycon pension Group accident insurance Formycon card Continuing education offers Team spirit, great working atmosphere and much more Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.