The main responsibilities of the candidate will be to support clinical and biology affairs for clinical and R&D
projects in collaboration between the CIBM and Volumina Medical. You will participate to in vivo
experiments, analysis of biological samples. Your missions will also include the writing of biology reports,
white papers and scientific documents, as well as clinical documents to be submitted to competent
regulatory and medical authorities for conducting clinical research. You will perform clinical literature
searches, literature searches about biological mechanisms and interact with KOLs and plastic surgeons and
dermatologists. You will also participate to the optimal implementation of the clinical studies under the
supervision of the clinical affairs manager.

The primary activities include but are not limited to:

• Biology activities:


• Perform in vivo experiments to understand the in vivo biological process taking place in the
  biomaterial (including participation in animal experiments, sample collection and processing,
  collection and analysis of technical and scientific data)


• Perform cell culture experiments


• Manage biology projects, interact with different teams to achieve the objectives of the project in
  a timely manner


• Perform literature research


• Write experimental plans and implement them


• Document all results according to guidelines and present results to the team

Clinical research activities:

• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor
  SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents


• Perform remote and on-site monitoring & oversight activities to ensure that the data generated at
  site is complete, accurate and unbiased;


• Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits, etc.) and
  document activities in reports in a timely manner.


• Collect, review and monitor the required regulatory documentation for study maintenance and
  study close-out


• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment,
  retention, protocol deviations, regulatory documentation, site audits/inspections and overall site
  performance


• Write clinical reports


• Participate to literature watch in the field of dermatology and aesthetic medicine

More information and application