Clinical Study Manager/Clinical Operation Manager (gn)

  • Medicine, Pharmacy, Laboratory
scheme image

Clinical Study Manager/Clinical Operation Manager (gn)

Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars.
With an experienced team comprised of more than 170 professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definiton 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

  • Represent Clinical Operations in cross-functional teams
  • Lead CRO interaction and oversight and serve as primary contact person
  • Assess continuously CRO performance
  • Participate in investigator meetings
  • Interact with national and international cooperation partners
  • Support review and revision of study related documentation (e.g. clinical trial protocol, patient information, clinical study report) and other functional documents (e.g. monitoring plan)
  • Identify and resolve any clinical trial related issues and risks
  • Participate in review activities (e.g. blinded data review meetings)
  • Participate in co-monitoring visits / on-site audits
  • Ensure compliance to time schedules and study budget
  • Ensure study-specific administration and archiving
  • Ensure compliance with operational quality standards in cooperation with QA
  • Harmonize internal and external clinical study activities to assure compliance to GCP, relevant guidelines and local laws
  • Support planning process of international clinical trials (Phase I - IV)
  • Support selection process of study vendors and trial sites
  • Support non-study related activities and department processes and procedures

Your qualifications

  • Degree in life sciences, medical/pharmaceutical sciences or a comparable field
  • At least 3 years work experience in CRO or pharma/biotech industry
  • Experience with Phase I – IV clinical trials
  • Thorough understanding relevant clinical trials and the regulations (AMG, GCP, ICH, FDA and EMA Clinical guidelines)
  • Experience in development of biological drugs / biosimilars preferable
  • Advanced computer skills (MS-Office)
  • Very good team player
  • Independent, organized and structured way of working
  • Proactive and problem solving skills
  • Fluent in written and spoken English, German knowledge preferable
  • Strong presentation, communication and networking skills
  • German work permit is mandatory

We offer

  • Flexible working time
  • mobile working
  • 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 46204