Additional clinical resource is required to support the ongoing IVDR remediation program, to ensure IVDR compliance in a timely manner. The Contigent Worker will support data generation through literature searches and data collation and dissemination. This will be in support of on-market products going through IVDR remediation. It is expected that the Contingent Worker will generate the initial clinical performance report, which then will be updated on an annual basis. The candidate will be skilled in medical writing, developing literature search protocols, and interpreting and selecting relevant scientific literature. Proficiency in Microsoft Word, including creating, tracking changes, and formatting documents to a final signable state, is essential.
Medical Writing and Study Execution:
Additional clinical resource is required to support the ongoing IVDR remediation program, to ensure IVDR compliance in a timely manner. The Clinical Project Manager will support data generation through literature searches and data collation and dissemination. This will be in support of on-market products going through IVDR remediation. It is expected that the Clinical Project Manager will generate the initial clinical performance report, which then will be updated on an annual basis. The Clinical Project Manager will be skilled in medical writing, developing literature search protocols, and interpreting and selecting relevant scientific literature. Proficiency in Microsoft Word, including creating, tracking changes, and formatting documents to a final signable state, is essential. Furthermore, Clinical Project Manager will also be skilled in clinical study start-up and execution. The Clinical Project Manager will provide support for IVDR study execution, as needed. The activities of this role will be in support of on-market products going through IVDR remediation as well as for new product requiring studies to comply with IVDR requirements.