Clinical Study Lead, Precision Medicine 2 positions | New role within MDx CRO's Precision Medicine team
Aumente sus posibilidades de conseguir una entrevista leyendo la siguiente descripción general de este puesto antes 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-
📌 Clinical Study Lead (Boiro)
🏢 MDx CRO
📍 Boiro