Senior Clinical Data Manager

Teoxane SA

Postuler
  • Date de publication :

    17 September 2023
  • Taux d'activité :

    100%
  • Type de contrat :

    Durée indéterminée
  • Lieu de travail :

    Genève

Vous retrouverez l'intégralité de nos offres d'emploi en cliquant ici : https://www.teoxane.com/.

Senior Clinical Data Manager

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.

In the frame of the growth of our business, we are looking for a :

Senior Clinical Data Manager

Main activities

  • Lead and manage all clinical data management activities on assigned clinical studies to deliver high quality data and meet the study milestones
  • Develop and review key deliverables such as Case Report Form, Data Validation Plan writing and programming, Data Management Plan, SAE reconciliation plan and Data Transfer Agreement, in compliance with international regulatory guidelines and internal SOPs
  • Perform or oversee the development and validation of the clinical database, execution of the user acceptance testing, data cleaning and quality control
  • Review and provide feedback on key clinical study documents
  • Act as the primary point of contact for Data Management with the study teams, CRO and external vendors. Coordinate the data management activities for outsourced clinical studies
  • Design and specify the reporting needs and dashboard to ensure clear data review
  • Participates in the development, review and implementation of internal SOPs, instructions and templates

Your profile

  • Minimum B.Sc. degree in a scientific or relevant discipline
  • Minimum 5 years of operational experience in clinical data management
  • Operational experience with a major EDC platforms (e.g. Merative, RAVE)
  • Proficiency in Microsoft Excel
  • Knowledge in biostatistics, SAS programming and PowerBI a plus
  • Excellent organizational and analytical/problem-solving skills
  • Ability to work independently, in a matrix environment and with virtual teams
  • Knowledge of ICH-GCP guidelines, CDISC and medical terminology
  • Fluent in French and English

Contact

Postuler