Clinical Study Lead, Precision Medicine 2 positions | New role within MDx CRO's Precision Medicine team

Usted podría ser el solicitante perfecto para este trabajo. Lea toda la información asociada y asegúrese de presentar su candidatura.

About the role MDx CRO is creating two new Clinical Study Lead positions within our Precision Medicine Clinical Alliances team.
This is not a conventional CRA role . It is not a purely regulatory role either.
It sits where biomarker science, investigational IVDs, clinical operations and drug development meet .
You will lead the IVD and biomarker study workstream within complex drug development programmes, translating regulatory strategy into country activation, testing site and clinical site execution, and high-quality study delivery.
You will need to move confidently between Competent Authorities, Ethics Committees, pharmaceutical sponsors, diagnostic partners, CRO teams, testing laboratories and clinical sites . You will understand not only how to obtain study approval,



but also how the diagnostic component must operate inside a clinical trial so that the resulting evidence remains robust and usable.
The role is international, client-facing and hands-on. International travel may be required for testing-site activities, monitoring, clinical sites, client meetings and other study activities.
What you will own
- Lead the IVD performance-study workstream within combined clinical trials and other biomarker-driven drug development programmes.
- Lead submission strategy and execution to National Competent Authorities and Ethics Committees , including initial applications or notifications, country adaptations, requests for information, amendments, substantial modifications and ongoing authority or committee correspondence.
- Coordinate the preparation and review of country submission packages, including CPSPs, relevant protocol content, informed consent language, site suitability documentation, national forms and other study-specific ma

📌 Clinical Study Lead (Vitoria-Gasteiz)
🏢 MDx CRO
📍 Vitoria-Gasteiz