Clinical Study Administrator (gn)

  • Junior, Career start
  • Medicine, Pharmacy, Laboratory
  • Research, development, teaching
  • Fulltime
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Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars.
With an experienced team comprised of more than 200 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.

Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 fusion protein.

To support our 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.

Your responsibilities

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

Your qualifications

  • 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

We offer

  • 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.

Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.

Our recruiting process is supported by the recruiter service by Constares GmbH. For initial questions, please contact Rebecca Schön: +49 89 1241 46 204.