Project Manager Clinical Evaluation (m/w/d), full-time

Andita Paramitha

Image
phenox Logo

phenox GmbH is a specialized manufacturer of Class III medical devices for the treatment of neurovascular diseases, which are developed, manufactured and distributed. Our innovative technologies and solutions are used by neuroradiologists worldwide to treat strokes and aneurysms. We offer a growing portfolio of innovative treatment options - including long-established technologies.

 To enlarge our clinical programs team we are looking as soon as possible for a

Project Manager Clinical Evaluation (m/w/d), full-time

Your job duties

  • You create and conduct clinical evaluations according to MDD 93/42/EEC / MDR 2017/745 as well as preparation of clinical summaries for international purposes including medical writing of all assigned documents
  • You conduct scientific literature and safety database searches according to state of the art and internal standard operation procedures
  • Creation, review and assessment of scientific publications are part of your tasks
  • Assessment of study designs and clinical studies and other clinical data collections including review of protocols and reports
  • You conduct all data analysis on clinical data generated for WallabyPhenox and competitor medical devices including development of optimized strategies for analysis
  • You work on clinical strategies for international submissions as well as preparation of clinical dossiers for submissions and answer deficiency reports of authorities
  • Generate and approve clinical evidence for promotional claims in marketing materials
  • You review and create clinical content of marketing materials and scientific booklets, flyers etc.
  • Preparation and accompanying internal and external audits and inspections, work in-line with standard operating procedures

your profile

  • Master’s degree in biostatistics, biology, chemistry, or a comparable field of study
  • PhD preferred, alternatively several years’ experience in the medical device industry and/or neurovascular therapeutic area
  • Data analysis and medical writing experiences
  • Experience in statistical analysis and in the medical device industry is a plus
  • Fluent business German and English
  • Work independently and be a great team player
  • Strong quality attitude; comfortable in working with other departments of the company (e.g., Quality management, R&D, Marketing)
  • Confident handling of literature management tools (EndNote) and Microsoft Office (Word, Excel, PowerPoint, Outlook, Visio etc.)

We Offer

  • an international & dynamic team
  • flexible working environment
  • a comprehensive on-boarding
  • possibility to evolve within the team
  • a fair and motivating remuneration system
  • pension scheme
  • company events/company celebrations
  • flat rate for drinks
  • JobRad

Does this appeal to you?

Then please send your complete documents, including the earliest possible starting date and your salary expectations, exclusively as a PDF file by e-mail to: 

bewerbung@wallabyphenox.com

Job Types: Full Time
Locations: Remote - Europe

Online Berwerbungsformular

Bitte trage alle mit einem * gekennzeichneten Felder aus, damit wir deine Bewerbungsunterlagen verarbeiten können.

Allowed Type(s): .pdf
Allowed Type(s): .pdf