(Senior) Product Owner (w/m/d) for the Healex Electronic Data Capture (EDC) in Cologne

We are Healex, a software start-up and consulting company from Cologne and Berlin, quickly becoming a leading digital health company. Our mission is to develop new products and solutions with your help for faster, data-driven clinical research and for the integration of health and research systems with the “FHIR” data standard.

Healex makes it possible to conduct clinical studies faster, more integrated and even more data-driven with structured clinical data and thereby speeding up the development of new therapies for fatal diseases.

The Healex Electronic Data Capture (EDC) is an innovative clinical database that facilitates and enables the complete digital capture of Case Report Forms (CRF) in clinical trials. Thus, the Healex EDC enables flexible modeling, as well as independent export and management of clinical reports for therapy consultation. With currently over 40 employees at our two locations, we are looking for you as an experienced (Senior) Product Owner for the Healex EDC.

Your tasks at Healex

  • You are in charge of our Electronic Data Capture System:
    • Create and maintain a product roadmap based on user requirements, business needs and technical constraints
    • You develop a suitable business case for the development resources and manage the backlog and feature development
    • You will make a decisive contribution to the development of the product strategy and positioning together with management and marketing
    • You make sure that the developers always have the correct requirements and all details of the development
    • You will work closely with product designers, marketing experts and UX specialists, gathering feedback from potential and new customers and prioritizing requirements
    • You manage the product life cycle and launch (and bury) the product functions together with marketing and customer support
  • You bring our team forward:
    • You will help to build and drive data-driven product development
    • You mediate between customer requirements, management and developer wishes

Your qualifications

  • Ideally, you have at least three years of experience in the pharmaceutical industry, a CRO, CCC, university hospital, research institute or a digital health start-up as product owner, product designer, product developer, clinical trial manager / project manager for clinical studies or study doctor
  • You have relevant experience in the development of complex software in agile environments and have made decisive contributions to the development of at least two products
  • You have a lot of experience in working with developers and customers
  • You speak both English and German fluently
  • You have good knowledge of the relevant guidelines and aspects of data management in clinical research
  • A successfully completed medical or natural science degree in biology, biochemistry, medicine or pharmacy or a successfully completed training as a pharmaceutical-technical assistant is welcome, but not mandatory. Alternatively, a degree in computer science or business informatics or similar training.
  • Optionally, you are also familiar with the following technologies and topics:
    • Clinical studies (phases I to IV and non-interventional studies), clinical research, pharmaceutical development, (clinical) site management including ICH GCP, applicable regulations and SOPs
    • Documentation (maintenance of the Site Master File / Investigator File / Trial Master File), site management
    • Knowledge of CDMS systems and Electronic Data Capture (EDC) systems
    • Clinical data standards: HL7 FHIR, HL7 v2, SNOMED CT
    • Basic knowledge of medical issues with focus on oncology
    • Scrum & Kanban

We offer you the best working environment

  • You will receive a permanent employment contract with room for your personal development and 30 days of holiday per year.
  • From day 1 you take over responsibility at one of the most successful digital health startups with locations in the middle of Cologne and Berlin
    You work on super exciting, innovative projects in the field of medical technologies and clinical data
    You can work flexibly – in the office, remote or home office (by arrangement)
  • We provide you with a company laptop, a free annual ticket for local transport and a mobile phone contract
  • Regular team events, flat hierarchies and short decision-making paths in a modern, agile company
  • We offer you extraordinary challenges and exciting future prospects.

We look forward to receiving your online application (cover letter, resume and certificates) to our Head of Software Development Alexander Szabo (jobs@healex.systems), if possible including any links to example code or projects (e.g. on GitHub).

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