Clinical Study Monitor (pk/pd & Biomarkers Focus)- Cdi- F/m
Pierre Fabre
Haute Garonne, France
Pk/pd and biomarker focus
Clinical study design and execution
Sample management oversight
This role ensures high-quality operational oversight of PK, PD, and biomarker components within early and late phase clinical trials, while contributing to regulatory documentation, study governance, sample management, and data integrity
Job Summary
This role ensures high-quality operational oversight of PK, PD, and biomarker components within early and late phase clinical trials, while contributing to regulatory documentation, study governance, sample management, and data integrity.
Key responsibilities include study design and operational support, sample and bioanalysis oversight, documentation and regulatory support, data management and analysis coordination, and study budget, planning, and vendor oversight.
Pierre Fabre offers an attractive remuneration/benefits package including incentives, profit-sharing, shareholding, health insurance, and additional holidays.
Matching Summary
This role ensures high-quality operational oversight of PK, PD, and biomarker components within early and late phase clinical trials, while contributing to regulatory documentation, study governance, sample management, and data integrity.
Skills & Requirements
Must-have
PK/PD and biomarker focus
Clinical study design and execution
Sample management oversight
Bioanalytical process compliance
Regulatory documentation accuracy
Data management and validation
Nice-to-have
Cross-functional collaboration
Proactive problem-solving
Attention to quality
Team-oriented mindset
Key Requirements
Master's degree or equivalent in Life Sciences, Pharmacy, Biology, Biomedical Sciences
Experience in clinical study conduct or operations
Good understanding of GCP and sample management
Experience with regulatory documentation
Prior interaction with CROs and external laboratories