Clinical Trial Physician – Phase I (EMEA)
Thermo Fisher Scientific · Portugal
وصف الوظيفة
About the role
Thermo Fisher Scientific is seeking an experienced Clinical Trial Physician to lead Phase I studies across the EMEA region. You will provide medical leadership to cross‑functional study teams, ensuring high‑quality data delivery within schedule and budget.
Key responsibilities
- Develop and review clinical trial protocols, amendments, CSRs, ICFs, CRFs and other study documents.
- Conduct real‑time medical monitoring of study endpoints and subject safety, escalating issues as needed.
- Interpret trial data for regulatory submissions (CSR, IND, NDA, MAA) and scientific publications.
- Serve as the primary medical contact for investigators, IRBs, health authorities and internal stakeholders.
- Provide medical training to site staff and ensure compliance with SOPs and GCP.
Required profile
- Medical degree with extensive experience in early‑phase clinical research.
- Proven ability to lead multidisciplinary teams and communicate complex medical information.
- Strong understanding of regulatory requirements and ethical standards.
Required skills
- Good Clinical Practice (GCP)
- Clinical trial protocol development
- Regulatory submission preparation (IND, NDA, MAA)
- Medical monitoring of clinical studies
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Thermo Fisher Scientific
Portugal
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