Activities will include but not be limited to:

●      Lead end-to-end clinical performance studies of IVD MD solutions

●      Coordinate studies with various stakeholders (internal and external) to ensure their efficient operational progress in terms of both deadlines and quality until archiving.

●      Draft documents related to the administrative submissions of clinical study projects, including the protocol.

●      Supervise, plan, and monitor all operations related to studies (selection of investigative sites, discussion with KOL, study start-up, monitoring, data management, statistical and clinical reports, archiving) in accordance with current regulatory requirements. (EU Regulation 2017/746).

●      Contribute to the quality system by participating in the drafting of procedures related to clinical studies.

●      Support the multi-disciplinary team (Product, Regulatory, Data Teams) in charge of the regulatory validation of our products.

●      Develop partnerships with manufacturers or pharmaceutical companies based on business logic.

●      Ingineer on medical environment or Pharm D, master’s degree or higher in life sciences or healthcare-related field.

●      3+ years of experience in clinical trial operations.

●      Experience in IVD MD -  FDA/CE certification and /or Oncology would be a plus.

●      Strong understanding of clinical research regulations and guidelines.

●      Ability to work independently and as part of a team.

●      Excellent communication, organizational, and problem-solving skills.

●      Fluent in English.

●      Proactive and solution-oriented.

●      Ability to work effectively in a fast-paced challenging environment within a growing company.

●      Very strong organizational and timeline management skills.

●      Experience of working within a multidisciplinary group and ability to work as part of a team.

●      Interest in AI and oncology.

• First ITW with our Chief Medical Officer.

• Second ITW with our Chief Operations Officer.

• Third ITW with our CEO.