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.
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